Viewing Study NCT03735667

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Ignite Creation Date: 2025-12-25 @ 12:52 AM
Ignite Modification Date: 2025-12-25 @ 11:07 PM
Study NCT ID: NCT03735667
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2025-12-10
First Post: 2018-11-06
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sarah.zanon@bsci.com', 'phone': '+41 79 840 7006', 'title': 'Sarah Zanon', 'organization': 'Boston Scientific'}, 'certainAgreement': {'otherDetails': 'A contractual agreement is in place between the PIs and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Trial-related factors\n\n* First RCT experience with ACURATE neo2 enrolled patients of all risks\n* Control arm included two comparator devices, with operator selection of preferred Control at time of randomization\n\nEnrollment factors\n\n* COVID - impact on staffing resources (hospital \\& sponsor support); supply constraints; investigational cases deprioritized relative to commercial cases\n* Operators less experienced with ACURATE neo2 compared to Control devices'}}, 'adverseEventsModule': {'timeFrame': '1 Year', 'description': 'Event reporting is required from randomization for the Main Randomized cohort and from index procedure for the Roll-in cohort. SAEs are reported by the sites through the end of study while AEs are reported through 1-year post-procedure.\n\nEvents are reported for the ITT population.', 'eventGroups': [{'id': 'EG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.', 'otherNumAtRisk': 752, 'deathsNumAtRisk': 752, 'otherNumAffected': 155, 'seriousNumAtRisk': 752, 'deathsNumAffected': 36, 'seriousNumAffected': 389}, {'id': 'EG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System.\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.', 'otherNumAtRisk': 748, 'deathsNumAtRisk': 748, 'otherNumAffected': 145, 'seriousNumAtRisk': 748, 'deathsNumAffected': 28, 'seriousNumAffected': 381}, {'id': 'EG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.', 'otherNumAtRisk': 148, 'deathsNumAtRisk': 148, 'otherNumAffected': 26, 'seriousNumAtRisk': 148, 'deathsNumAffected': 7, 'seriousNumAffected': 81}], 'otherEvents': [{'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 50, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 48, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 122, 'numAffected': 121}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 114, 'numAffected': 111}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Catheter site haematoma', 'notes': 'and Administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Anaemia vitamin B12 deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cold type haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Haemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Heparin-induced thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Lymphadenopathy mediastinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Aortic valve thickening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Arteriospasm coronary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 37, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 40, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Atrial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 53, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 70, 'numAffected': 68}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Bundle branch block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 28, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cardiac perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 3, 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1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Vascular occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 752, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 748, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Composite Rate of All-cause Mortality, All Stroke, and Rehospitalization* at 1 Year in the Main Randomized Cohort.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.16', 'groupId': 'OG000', 'lowerLimit': '13.38', 'upperLimit': '19.07'}, {'value': '9.53', 'groupId': 'OG001', 'lowerLimit': '7.47', 'upperLimit': '11.89'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A Bayesian analysis based on 10,000 samples from the posterior distribution, using a piecewise exponential survival model. The criteria for non-inferiority is met if the posterior probability of non-inferiority is greater than the non-inferiority test threshold.', 'otherAnalysisDescription': 'A Bayesian analysis was used to test the non-inferiority hypothesis for the primary endpoint using a non-inferiority margin of 8%. The pre-specified success criteria (the non-inferiority test threshold) was a posterior probability of non-inferiority greater than 97.5%. The observed posterior probability of non-inferiority was 77.9%. The posterior median percentage difference in the rate of the primary outcome was 6.63% (95% Bayesian credible interval: 3.04% to 10.20%).'}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed for the duration of hospital stay through 1 year.', 'description': 'Primary Endpoint: A Clinical Events Committee (CEC), independent group of physician experts reviewed and adjudicated all reported cases of death, stroke and rehospitalization to determine whether they met the specific protocol definition of the event. The CEC adjudicated results are used in the endpoint analysis.\n\n\\* Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV); per VARC-2 definition.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'title': 'Mortality: all-cause at Discharge/7 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Mortality: cardiovascular at Discharge/7 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Mortality: non-cardiovascular at Discharge/7 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mortality: all-cause at 30 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Mortality: cardiovascular at 30 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Mortality: non-cardiovascular at 30 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mortality: all-cause at 6 Months Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Mortality: cardiovascular at 6 Months Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Mortality: non-cardiovascular at 6 Months Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mortality: all-cause at 1 Year Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '719', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}, {'value': '3.9', 'groupId': 'OG001'}, {'value': '4.8', 'groupId': 'OG002'}]}]}, {'title': 'Mortality: cardiovascular at 1 Year Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '719', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '3.4', 'groupId': 'OG002'}]}]}, {'title': 'Mortality: non-cardiovascular at 1 Year Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '719', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definition.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.\n\nEvaluable for clinical endpoints at 30 days/6 Months/1 Year is defined as subjects who experience an event through 30 days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of All Stroke: Disabling and Non-disabling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'title': 'All stroke at Discharge/7 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Disabling stroke at Discharge/7 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Non-disabling stroke at Discharge/7 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'All stroke at 30 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Disabling stroke at 30 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Non-disabling stroke at 30 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'All stroke at 6 Months Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}, {'value': '5.4', 'groupId': 'OG002'}]}]}, {'title': 'Disabling stroke at 6 Months Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Non-disabling stroke at 6 Months Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}, {'value': '4.1', 'groupId': 'OG002'}]}]}, {'title': 'All stroke at 1 Year Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '719', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}, {'value': '3.5', 'groupId': 'OG001'}, {'value': '7.5', 'groupId': 'OG002'}]}]}, {'title': 'Disabling stroke at 1 Year Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '719', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'Non-disabling stroke at 1 Year Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '719', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}, {'value': '5.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definition.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.\n\nEvaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'title': 'MI at Discharge/7 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Periprocedural MI at Discharge/7 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Spontaneous MI at Discharge/7 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'MI at 30 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Periprocedural MI at 30 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Spontaneous MI at 30 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'MI at 6 Months Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Periprocedural MI at 6 Months Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Spontaneous MI at 6 Months Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'MI at 1 Year Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '719', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Periprocedural MI at 1 Year Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '719', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Spontaneous MI at 1 Year Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '719', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.\n\nEvaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Bleeding: Life-threatening (or Disabling) and Major', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'title': 'Life-threatening or disabling bleeding at Discharge/7 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '2.0', 'groupId': 'OG002'}]}]}, {'title': 'Major bleeding at Discharge/7 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Life-threatening or disabling bleeding at 30 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '2.0', 'groupId': 'OG002'}]}]}, {'title': 'Major bleeding at 30 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Life-threatening or disabling bleeding at 6 Months Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '2.3', 'groupId': 'OG001'}, {'value': '2.0', 'groupId': 'OG002'}]}]}, {'title': 'Major bleeding at 6 Months Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}, {'value': '2.7', 'groupId': 'OG002'}]}]}, {'title': 'Life-threatening or disabling bleeding at 1 Year Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '719', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}, {'value': '2.7', 'groupId': 'OG002'}]}]}, {'title': 'Major bleeding at 1 Year Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '719', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}, {'value': '3.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.\n\nEvaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Major Vascular Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'title': 'Discharge/7 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}]}]}, {'title': '30 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}]}]}, {'title': '6 Months Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}, {'value': '2.0', 'groupId': 'OG002'}]}]}, {'title': '1 Year Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '719', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}, {'value': '2.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.\n\nEvaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Repeat Procedure for Valve-related Dysfunction (Surgical or Interventional Therapy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'title': 'Discharge/7 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '30 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '6 Months Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}, {'title': '1 Year Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '719', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.\n\nEvaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure (NYHA Class III or IV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'title': 'Discharge/7 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '30 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '3.4', 'groupId': 'OG002'}]}]}, {'title': '6 Months Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}, {'value': '4.1', 'groupId': 'OG002'}]}]}, {'title': '1 Year Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '719', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}, {'value': '3.5', 'groupId': 'OG001'}, {'value': '4.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.\n\nEvaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of New Permanent Pacemaker Implantation (PPI) Resulting From New or Worsened Conduction Disturbances', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'title': 'Discharge/7 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}]}]}, {'title': '30 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000'}, {'value': '9.5', 'groupId': 'OG001'}, {'value': '4.7', 'groupId': 'OG002'}]}]}, {'title': '6 Months Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000'}, {'value': '10.9', 'groupId': 'OG001'}, {'value': '7.4', 'groupId': 'OG002'}]}]}, {'title': '1 Year Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '719', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000'}, {'value': '12.2', 'groupId': 'OG001'}, {'value': '8.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.\n\nEvaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of New Onset of Atrial Fibrillation or Atrial Flutter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'title': 'New onset of atrial fibrillation at Discharge/7 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}, {'value': '2.7', 'groupId': 'OG002'}]}]}, {'title': 'New onset of atrial flutter at Discharge/7 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'New onset of atrial fibrillation at 30 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}, {'value': '3.4', 'groupId': 'OG002'}]}]}, {'title': 'New onset of atrial flutter at 30 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'New onset of atrial fibrillation at 6 Months Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}, {'value': '2.3', 'groupId': 'OG001'}, {'value': '3.4', 'groupId': 'OG002'}]}]}, {'title': 'New onset of atrial flutter at 6 Months Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'New onset of atrial fibrillation at 1 Year Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '719', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}, {'value': '3.4', 'groupId': 'OG002'}]}]}, {'title': 'New onset of atrial flutter at 1 Year Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '719', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.\n\nEvaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Acute Kidney Injury (AKI; ≤7 Days Post Index Procedure): Based on the AKIN System Stage 3 (Including Renal Replacement Therapy) or Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'title': 'Acute kidney injury based on AKIN System Stage 3 (including renal replacement therapy) or Stage 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Acute kidney injury based on AKIN System Stage 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Acute kidney injury based on AKIN System Stage 3 (including renal replacement therapy)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed peri- and post-procedure, through 7 days post index procedure.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Coronary Obstruction: Periprocedural', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed through 72 hours post index procedure', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) - based on VARC endpoints and definitions.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Ventricular Septal Perforation: Periprocedural', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed through 72 hours post index procedure', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Mitral Apparatus Damage: Periprocedural', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed through 72 hours post index procedure', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Cardiac Tamponade: Periprocedural', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo 2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed through 72 hours post index procedure', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Valve Migration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'title': 'Discharge/7 Days Post-Randomization (whichever comes first)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': '30 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': '6 Months Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': '1 Year Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '719', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.\n\nEvaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Valve Embolization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'title': 'Discharge/7 Days Post-Randomization (whichever comes first)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': '30 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': '6 Months Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': '1 Year Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '719', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.\n\nEvaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Ectopic Valve Deployment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed peri- and post-procedure through discharge or 7 days post-procedure (whichever comes first).', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Transcatheter Aortic Valve (TAV)-In-TAV Deployment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'title': 'Discharge/7 Days Post- Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': '30 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': '6 Months Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}, {'title': '1 Year Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '719', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.\n\nEvaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Prosthetic Aortic Valve Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'title': 'Discharge/7 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': '30 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': '6 Months Post -Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': '1 Year Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '719', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.\n\nEvaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Prosthetic Aortic Valve Endocarditis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'title': 'Discharge/7 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': '30 Days Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': '6 Months Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '729', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': '1 Year Post-Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '719', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.\n\nEvaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Successful Vascular Access, Delivery and Deployment of the Study Valve, and Successful Retrieval of the Delivery System (Site Reported Assessment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000'}, {'value': '99.3', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed for the duration of their procedure, an expected average of 1 Day (peri- and post-procedure)', 'description': 'Device Performance outcome, as measured by site reported data based on VARC-2 endpoints and definitions.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'title': 'Total aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - None/Trace', 'denoms': [{'units': 'Participants', 'counts': [{'value': '721', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '74.9', 'groupId': 'OG000'}, {'value': '85.9', 'groupId': 'OG001'}, {'value': '68.5', 'groupId': 'OG002'}]}]}, {'title': 'Total aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '721', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000'}, {'value': '13.8', 'groupId': 'OG001'}, {'value': '29.5', 'groupId': 'OG002'}]}]}, {'title': 'Total aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '721', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'Total aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '721', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Central aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - None/Trace', 'denoms': [{'units': 'Participants', 'counts': [{'value': '721', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000'}, {'value': '99.9', 'groupId': 'OG001'}, {'value': '97.3', 'groupId': 'OG002'}]}]}, {'title': 'Central aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '721', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '2.7', 'groupId': 'OG002'}]}]}, {'title': 'Central aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '721', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Central aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '721', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Aortic paravalvular regurgitation (PVL) at Discharge/7 Days Post-Procedure - None/Trace', 'denoms': [{'units': 'Participants', 'counts': [{'value': '721', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '75.9', 'groupId': 'OG000'}, {'value': '86.1', 'groupId': 'OG001'}, {'value': '70.5', 'groupId': 'OG002'}]}]}, {'title': 'Aortic paravalvular regurgitation (PVL) at Discharge/7 Days Post-Procedure - Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '721', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000'}, {'value': '13.6', 'groupId': 'OG001'}, {'value': '28.1', 'groupId': 'OG002'}]}]}, {'title': 'Aortic paravalvular regurgitation (PVL) at Discharge/7 Days Post-Procedure - Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '721', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Aortic paravalvular regurgitation (PVL) at Discharge/7 Days Post-Procedure - Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '721', 'groupId': 'OG000'}, {'value': '726', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Total aortic regurgitation (AR) at 30 Days Post-Procedure - None/Trace', 'denoms': [{'units': 'Participants', 'counts': [{'value': '691', 'groupId': 'OG000'}, {'value': '695', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '75.5', 'groupId': 'OG001'}, {'value': '52.2', 'groupId': 'OG002'}]}]}, {'title': 'Total aortic regurgitation (AR) at 30 Days Post-Procedure - Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '691', 'groupId': 'OG000'}, {'value': '695', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '38.6', 'groupId': 'OG000'}, {'value': '23.5', 'groupId': 'OG001'}, {'value': '44.9', 'groupId': 'OG002'}]}]}, {'title': 'Total aortic regurgitation (AR) at 30 Days Post-Procedure - Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '691', 'groupId': 'OG000'}, {'value': '695', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}, {'value': '2.9', 'groupId': 'OG002'}]}]}, {'title': 'Total aortic regurgitation (AR) at 30 Days Post-Procedure - Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '691', 'groupId': 'OG000'}, {'value': '695', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Central aortic regurgitation (AR) at 30 Days Post-Procedure - None/Trace', 'denoms': [{'units': 'Participants', 'counts': [{'value': '691', 'groupId': 'OG000'}, {'value': '695', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000'}, {'value': '99.9', 'groupId': 'OG001'}, {'value': '97.1', 'groupId': 'OG002'}]}]}, {'title': 'Central aortic regurgitation (AR) at 30 Days Post-Procedure - Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '691', 'groupId': 'OG000'}, {'value': '695', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '2.9', 'groupId': 'OG002'}]}]}, {'title': 'Central aortic regurgitation (AR) at 30 Days Post-Procedure - Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '691', 'groupId': 'OG000'}, {'value': '695', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Central aortic regurgitation (AR) at 30 Days Post-Procedure - Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '691', 'groupId': 'OG000'}, {'value': '695', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Aortic paravalvular regurgitation (PVL) at 30 Days Post-Procedure - None/Trace', 'denoms': [{'units': 'Participants', 'counts': [{'value': '691', 'groupId': 'OG000'}, {'value': '695', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '58.5', 'groupId': 'OG000'}, {'value': '75.8', 'groupId': 'OG001'}, {'value': '54.3', 'groupId': 'OG002'}]}]}, {'title': 'Aortic paravalvular regurgitation (PVL) at 30 Days Post-Procedure - Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '691', 'groupId': 'OG000'}, {'value': '695', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '38.1', 'groupId': 'OG000'}, {'value': '23.2', 'groupId': 'OG001'}, {'value': '42.8', 'groupId': 'OG002'}]}]}, {'title': 'Aortic paravalvular regurgitation (PVL) at 30 Days Post-Procedure - Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '691', 'groupId': 'OG000'}, {'value': '695', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}, {'value': '2.9', 'groupId': 'OG002'}]}]}, {'title': 'Aortic paravalvular regurgitation (PVL) at 30 Days Post-Procedure - Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '691', 'groupId': 'OG000'}, {'value': '695', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Total aortic regurgitation (AR) at 6 Months Post-Procedure - None/Trace', 'denoms': [{'units': 'Participants', 'counts': [{'value': '612', 'groupId': 'OG000'}, {'value': '627', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '53.0', 'groupId': 'OG000'}, {'value': '70.1', 'groupId': 'OG001'}, {'value': '57.3', 'groupId': 'OG002'}]}]}, {'title': 'Total aortic regurgitation (AR) at 6 Months Post-Procedure - Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '612', 'groupId': 'OG000'}, {'value': '627', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41.8', 'groupId': 'OG000'}, {'value': '29.2', 'groupId': 'OG001'}, {'value': '38.5', 'groupId': 'OG002'}]}]}, {'title': 'Total aortic regurgitation (AR) at 6 Months Post-Procedure - Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '612', 'groupId': 'OG000'}, {'value': '627', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}, {'value': '4.3', 'groupId': 'OG002'}]}]}, {'title': 'Total aortic regurgitation (AR) at 6 Months Post-Procedure - Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '612', 'groupId': 'OG000'}, {'value': '627', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Central aortic regurgitation (AR) at 6 Months Post-Procedure - None/Trace', 'denoms': [{'units': 'Participants', 'counts': [{'value': '612', 'groupId': 'OG000'}, {'value': '627', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '96.6', 'groupId': 'OG000'}, {'value': '99.0', 'groupId': 'OG001'}, {'value': '96.6', 'groupId': 'OG002'}]}]}, {'title': 'Central aortic regurgitation (AR) at 6 Months Post-Procedure - Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '612', 'groupId': 'OG000'}, {'value': '627', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}, {'value': '3.4', 'groupId': 'OG002'}]}]}, {'title': 'Central aortic regurgitation (AR) at 6 Months Post-Procedure - Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '612', 'groupId': 'OG000'}, {'value': '627', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Central aortic regurgitation (AR) at 6 Months Post-Procedure - Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '612', 'groupId': 'OG000'}, {'value': '627', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Aortic paravalvular regurgitation (PVL) at 6 Months Post-Procedure - None/Trace', 'denoms': [{'units': 'Participants', 'counts': [{'value': '612', 'groupId': 'OG000'}, {'value': '627', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '54.6', 'groupId': 'OG000'}, {'value': '71.0', 'groupId': 'OG001'}, {'value': '58.1', 'groupId': 'OG002'}]}]}, {'title': 'Aortic paravalvular regurgitation (PVL) at 6 Months Post-Procedure - Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '612', 'groupId': 'OG000'}, {'value': '627', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '40.8', 'groupId': 'OG000'}, {'value': '28.2', 'groupId': 'OG001'}, {'value': '37.6', 'groupId': 'OG002'}]}]}, {'title': 'Aortic paravalvular regurgitation (PVL) at 6 Months Post-Procedure - Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '612', 'groupId': 'OG000'}, {'value': '627', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}, {'value': '4.3', 'groupId': 'OG002'}]}]}, {'title': 'Aortic paravalvular regurgitation (PVL) at 6 Months Post-Procedure - Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '612', 'groupId': 'OG000'}, {'value': '627', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Total aortic regurgitation (AR) at 1 Year Post-Procedure - None/Trace', 'denoms': [{'units': 'Participants', 'counts': [{'value': '616', 'groupId': 'OG000'}, {'value': '628', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG000'}, {'value': '73.4', 'groupId': 'OG001'}, {'value': '64.2', 'groupId': 'OG002'}]}]}, {'title': 'Total aortic regurgitation (AR) at 1 Year Post-Procedure - Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '616', 'groupId': 'OG000'}, {'value': '628', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '42.5', 'groupId': 'OG000'}, {'value': '24.8', 'groupId': 'OG001'}, {'value': '32.5', 'groupId': 'OG002'}]}]}, {'title': 'Total aortic regurgitation (AR) at 1 Year Post-Procedure - Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '616', 'groupId': 'OG000'}, {'value': '628', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '3.3', 'groupId': 'OG002'}]}]}, {'title': 'Total aortic regurgitation (AR) at 1 Year Post-Procedure - Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '616', 'groupId': 'OG000'}, {'value': '628', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Central aortic regurgitation (AR) at 1 Year Post-Procedure - None/Trace', 'denoms': [{'units': 'Participants', 'counts': [{'value': '616', 'groupId': 'OG000'}, {'value': '628', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000'}, {'value': '99.4', 'groupId': 'OG001'}, {'value': '95.9', 'groupId': 'OG002'}]}]}, {'title': 'Central aortic regurgitation (AR) at 1 Year Post-Procedure - Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '616', 'groupId': 'OG000'}, {'value': '628', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}, {'value': '4.1', 'groupId': 'OG002'}]}]}, {'title': 'Central aortic regurgitation (AR) at 1 Year Post-Procedure - Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '616', 'groupId': 'OG000'}, {'value': '628', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Central aortic regurgitation (AR) at 1 Year Post-Procedure - Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '616', 'groupId': 'OG000'}, {'value': '628', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Aortic paravalvular regurgitation (PVL) at 1 Year Post-Procedure - None/Trace', 'denoms': [{'units': 'Participants', 'counts': [{'value': '616', 'groupId': 'OG000'}, {'value': '628', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '55.5', 'groupId': 'OG000'}, {'value': '74.0', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}]}]}, {'title': 'Aortic paravalvular regurgitation (PVL) at 1 Year Post-Procedure - Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '616', 'groupId': 'OG000'}, {'value': '628', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '40.7', 'groupId': 'OG000'}, {'value': '24.2', 'groupId': 'OG001'}, {'value': '30.9', 'groupId': 'OG002'}]}]}, {'title': 'Aortic paravalvular regurgitation (PVL) at 1 Year Post-Procedure - Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '616', 'groupId': 'OG000'}, {'value': '628', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '2.4', 'groupId': 'OG002'}]}]}, {'title': 'Aortic paravalvular regurgitation (PVL) at 1 Year Post-Procedure - Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '616', 'groupId': 'OG000'}, {'value': '628', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be assessed pre-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years, 7 years, and 10 years will be posted once data is complete.', 'description': 'Grade of Aortic Regurgitation as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.\n\nNumber analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Device Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'title': 'Device Success', 'categories': [{'measurements': [{'value': '74.1', 'groupId': 'OG000'}, {'value': '81.8', 'groupId': 'OG001'}, {'value': '57.0', 'groupId': 'OG002'}]}]}, {'title': 'Absence of procedural mortality', 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}]}]}, {'title': 'Correct positioning of a single valve into the proper anatomical location', 'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000'}, {'value': '99.1', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}]}]}, {'title': 'Intended performance of the study device', 'categories': [{'measurements': [{'value': '75.8', 'groupId': 'OG000'}, {'value': '82.5', 'groupId': 'OG001'}, {'value': '57.0', 'groupId': 'OG002'}]}]}, {'title': 'iEOA >0.85 cm2/m2 for BMI <30 kg/m2 and iEOA >0.70 cm2/m2 for BMI ≥30 kg/m2 (AND)', 'categories': [{'measurements': [{'value': '77.0', 'groupId': 'OG000'}, {'value': '83.7', 'groupId': 'OG001'}, {'value': '60.4', 'groupId': 'OG002'}]}]}, {'title': 'Mean aortic valve gradient <20 mmHg OR peak velocity <3m/sec (AND)', 'categories': [{'measurements': [{'value': '99.0', 'groupId': 'OG000'}, {'value': '98.3', 'groupId': 'OG001'}, {'value': '96.5', 'groupId': 'OG002'}]}]}, {'title': 'No moderate or severe prosthetic valve aortic regurgitation', 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000'}, {'value': '99.7', 'groupId': 'OG001'}, {'value': '97.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed for the duration of their procedure, an expected average of 1 Day (post-procedure)', 'description': 'Absence of procedural mortality, correct positioning of a single transcatheter valve in the proper anatomical location, and intended performance of the study device (indexed effective orifice area \\[iEOA\\] \\>0.85 cm2/m2 for BMI \\<30 kg/cm2 and iEOA \\>0.70 cm2/m2 for BMI ≥30 kg/cm2 plus either a mean aortic valve gradient \\<20 mmHg or a peak velocity \\< 3m, and no moderate or severe prosthetic valve aortic regurgitation) based on VARC-2 endpoints and definitions.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Effective Orifice Area (EOA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'title': 'Discharge/7 Days Post-Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'OG000'}, {'value': '663', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.77', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '1.82', 'spread': '032', 'groupId': 'OG001'}, {'value': '1.68', 'spread': '0.34', 'groupId': 'OG002'}]}]}, {'title': '30 Days Post-Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '645', 'groupId': 'OG000'}, {'value': '651', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.76', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '1.78', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '1.65', 'spread': '0.34', 'groupId': 'OG002'}]}]}, {'title': '6 Months Post-Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '576', 'groupId': 'OG000'}, {'value': '589', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.76', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '1.77', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '1.65', 'spread': '0.31', 'groupId': 'OG002'}]}]}, {'title': '1 Year Post-Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '573', 'groupId': 'OG000'}, {'value': '581', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.77', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '1.78', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '1.64', 'spread': '0.32', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Participants will be assessed pre-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years, 7 years, and 10 years will be posted once data is complete.', 'description': 'Effective Orifice Area (EOA), as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory', 'unitOfMeasure': 'cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.\n\nNumber analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Aortic Gradient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'title': 'Discharge/7 Days Post-Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '704', 'groupId': 'OG000'}, {'value': '708', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.0', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '4.2', 'groupId': 'OG001'}, {'value': '10.0', 'spread': '4.7', 'groupId': 'OG002'}]}]}, {'title': '30 Days Post-Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '679', 'groupId': 'OG000'}, {'value': '685', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '4.7', 'groupId': 'OG001'}, {'value': '8.1', 'spread': '3.3', 'groupId': 'OG002'}]}]}, {'title': '6 Months Post-Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '604', 'groupId': 'OG000'}, {'value': '616', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '8.1', 'spread': '4.0', 'groupId': 'OG002'}]}]}, {'title': '1 Year Post-Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '604', 'groupId': 'OG000'}, {'value': '615', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.9', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '5.0', 'groupId': 'OG001'}, {'value': '8.4', 'spread': '3.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Participants will be assessed pre-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years, 7 years, and 10 years will be posted once data is complete.', 'description': 'Mean Aortic Gradient as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.\n\nNumber analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'New York Heart Association (NYHA) Functional Status Classification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'title': 'Discharge/7 Days Post Procedure NYHA Functional Class - I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '715', 'groupId': 'OG000'}, {'value': '716', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.1', 'groupId': 'OG000'}, {'value': '32.0', 'groupId': 'OG001'}, {'value': '32.7', 'groupId': 'OG002'}]}]}, {'title': 'Discharge/7 Days Post-Procedure NYHA Functional Class - II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '715', 'groupId': 'OG000'}, {'value': '716', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '49.4', 'groupId': 'OG000'}, {'value': '52.4', 'groupId': 'OG001'}, {'value': '49.0', 'groupId': 'OG002'}]}]}, {'title': 'Discharge/7 Days Post-Procedure NYHA Functional Class - III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '715', 'groupId': 'OG000'}, {'value': '716', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000'}, {'value': '15.5', 'groupId': 'OG001'}, {'value': '18.4', 'groupId': 'OG002'}]}]}, {'title': 'Discharge/7 Days Post-Procedure NYHA Functional Class - IV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '715', 'groupId': 'OG000'}, {'value': '716', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': '30 Days Post-Procedure NYHA Functional Class - I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'OG000'}, {'value': '694', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '57.7', 'groupId': 'OG000'}, {'value': '60.1', 'groupId': 'OG001'}, {'value': '57.2', 'groupId': 'OG002'}]}]}, {'title': '30 Days Post-Procedure NYHA Functional Class - II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'OG000'}, {'value': '694', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '37.8', 'groupId': 'OG000'}, {'value': '35.0', 'groupId': 'OG001'}, {'value': '39.3', 'groupId': 'OG002'}]}]}, {'title': '30 Days Post-Procedure NYHA Functional Class - III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'OG000'}, {'value': '694', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '4.9', 'groupId': 'OG001'}, {'value': '3.4', 'groupId': 'OG002'}]}]}, {'title': '30 Days Post-Procedure NYHA Functional Class - IV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'OG000'}, {'value': '694', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': '6 Months Post-Procedure NYHA Functional Class - I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '633', 'groupId': 'OG000'}, {'value': '634', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '65.1', 'groupId': 'OG000'}, {'value': '66.2', 'groupId': 'OG001'}, {'value': '64.4', 'groupId': 'OG002'}]}]}, {'title': '6 Months Post-Procedure NYHA Functional Class - II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '633', 'groupId': 'OG000'}, {'value': '634', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.9', 'groupId': 'OG000'}, {'value': '29.3', 'groupId': 'OG001'}, {'value': '31.1', 'groupId': 'OG002'}]}]}, {'title': '6 Months Post-Procedure NYHA Functional Class - III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '633', 'groupId': 'OG000'}, {'value': '634', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000'}, {'value': '4.4', 'groupId': 'OG001'}, {'value': '4.5', 'groupId': 'OG002'}]}]}, {'title': '6 Months Post-Procedure NYHA Functional Class - IV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '633', 'groupId': 'OG000'}, {'value': '634', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': '1 Year Post-Procedure NYHA Functional Class - I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '630', 'groupId': 'OG000'}, {'value': '630', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '64.9', 'groupId': 'OG000'}, {'value': '64.4', 'groupId': 'OG001'}, {'value': '60.3', 'groupId': 'OG002'}]}]}, {'title': '1 Year Post-Procedure NYHA Functional Class - II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '630', 'groupId': 'OG000'}, {'value': '630', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.9', 'groupId': 'OG000'}, {'value': '31.1', 'groupId': 'OG001'}, {'value': '35.7', 'groupId': 'OG002'}]}]}, {'title': '1 Year Post-Procedure NYHA Functional Class - III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '630', 'groupId': 'OG000'}, {'value': '630', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '4.4', 'groupId': 'OG001'}, {'value': '4.0', 'groupId': 'OG002'}]}]}, {'title': '1 Year Post-Procedure NYHA Functional Class - IV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '630', 'groupId': 'OG000'}, {'value': '630', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years, 7 years, and 10 years will be posted once data is complete.', 'description': 'Health status evaluated by New York Heart Association (NYHA) Classification.\n\nNYHA Classification:\n\nClass I: Subjects with cardiac disease but without resulting limitations of physical activity.\n\nClass I: Subjects with cardiac disease resulting in slight limitation of physical activity.\n\nClass III: Subjects with cardiac disease resulting in marked limitation of physical activity.\n\nClass IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.\n\nNYHA class denominator is the number of subjects with non-missing NYHA class at the studied timepoint.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Assessment - Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'title': 'Baseline - Overall Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '737', 'groupId': 'OG000'}, {'value': '739', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '62.4', 'spread': '22.3', 'groupId': 'OG000'}, {'value': '62.2', 'spread': '21.9', 'groupId': 'OG001'}, {'value': '62.0', 'spread': '21.5', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to 30 Days - Overall Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '700', 'groupId': 'OG000'}, {'value': '701', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18.1', 'spread': '21.6', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '22.1', 'groupId': 'OG001'}, {'value': '19.8', 'spread': '21.1', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to 1 Year - Overall Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '631', 'groupId': 'OG000'}, {'value': '628', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.4', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '20.0', 'spread': '22.1', 'groupId': 'OG001'}, {'value': '19.8', 'spread': '20.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Participants will be assessed at baseline, 30 Days, and 1 Year. Data for 5 years will be posted once data is complete.', 'description': 'Health Status additional outcome KCCQ Analysis - Overall Summary Score change from Baseline.\n\nKansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.\n\nOverall Summary Score - mean of score 1, 5, 7, and 8', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.\n\nNote: paired analysis includes subjects with non-missing data at both baseline and the specific follow-up visit.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '748', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'OG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'classes': [{'title': 'Baseline - Physical Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '732', 'groupId': 'OG000'}, {'value': '735', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '36.9', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '36.1', 'spread': '11.0', 'groupId': 'OG001'}, {'value': '36.4', 'spread': '10.2', 'groupId': 'OG002'}]}]}, {'title': 'Baseline - Mental Health Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '732', 'groupId': 'OG000'}, {'value': '735', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '51.7', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '51.8', 'spread': '10.3', 'groupId': 'OG001'}, {'value': '51.6', 'spread': '9.1', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to 30 Days - Physical Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}, {'value': '691', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '10.5', 'groupId': 'OG001'}, {'value': '5.7', 'spread': '10.6', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to 30 Days - Mental Health Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}, {'value': '691', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '11.1', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '10.7', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to 1 Year - Physical Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '626', 'groupId': 'OG000'}, {'value': '622', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '11.5', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '10.2', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to 1 Year - Mental Health Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '626', 'groupId': 'OG000'}, {'value': '622', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '11.1', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '10.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Participants will be assessed at baseline, 30 Days, and 1 Year. Data for 5 years will be posted once data is complete.', 'description': 'Health Status outcome - SF-12 - Baseline scores and changes from Baseline at 30 Days and 1 Year.\n\n12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.\n\nNote: paired analysis includes subjects with non-missing data at both baseline and the specific follow-up visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'FG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'FG002', 'title': 'ACURATE neo 2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}], 'periods': [{'title': '1 Year PE Main Randomized and Roll-in', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '752'}, {'groupId': 'FG001', 'numSubjects': '748'}, {'groupId': 'FG002', 'numSubjects': '148'}]}, {'type': 'Eligible 1-Year', 'achievements': [{'groupId': 'FG000', 'numSubjects': '716'}, {'groupId': 'FG001', 'numSubjects': '720'}, {'groupId': 'FG002', 'numSubjects': '141'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '649'}, {'groupId': 'FG001', 'numSubjects': '658'}, {'groupId': 'FG002', 'numSubjects': '130'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '90'}, {'groupId': 'FG002', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': '1-Year Visit Not Done', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': '4D-CT Substudy (subset of Main RCT)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '158'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Eligible 1 Year 4D-CT', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '154'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '144'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': '1-Year Visit Not Done', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Main Randomized Cohort: 1500 subjects randomized from 10Jun2019 to 19Apr2023. Roll-in Cohort: 148 subjects enrolled from 10Jul2019 to 27Feb2023.', 'preAssignmentDetails': 'The non-randomized Roll-in phase with only the test device was for centers with no previous experience implanting ACURATE. Each applicable site performed at least two Roll-in cases before starting enrollment in the Main Randomized Cohort.\n\nOnly data for the Main Randomized Cohort and Roll-in Cohort are being reported at this time as data for the 4D-CT Substudy and other 3 cohorts (Continued Access Study, Extended Durability, and Prime XL Nested Registry) are not available.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'ACURATE neo2 Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'BG001', 'title': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR,Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.'}, {'id': 'BG002', 'title': 'ACURATE neo2 Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '78.0', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '79.0', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '78.8', 'spread': '7.1', 'groupId': 'BG002'}, {'value': '78.5', 'spread': '6.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '357', 'groupId': 'BG000'}, {'value': '364', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '785', 'groupId': 'BG003'}]}]}, {'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '395', 'groupId': 'BG000'}, {'value': '383', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '862', 'groupId': 'BG003'}]}]}, {'title': 'Intersex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}, {'title': 'Asian - Chinese', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Asian - Japanese', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Asian - Korean', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Other Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}]}, {'title': 'Caucasian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '675', 'groupId': 'BG000'}, {'value': '659', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '1471', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}, {'title': 'Not Disclosed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic or Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Note - As subjects had the option to select more than one race/ethnicity, the sum of participants in this Baseline Measure does not equal the overall number of Baseline Participants in each Arm/Group.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '693', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1528', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '30.6', 'spread': '6.5', 'groupId': 'BG000'}, {'value': '29.8', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '31.5', 'spread': '7.8', 'groupId': 'BG002'}, {'value': '30.3', 'spread': '6.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Aortic Annulus Area', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '435.2', 'spread': '58.7', 'groupId': 'BG000'}, {'value': '437.3', 'spread': '54.7', 'groupId': 'BG001'}, {'value': '439.6', 'spread': '56.6', 'groupId': 'BG002'}, {'value': '436.5', 'spread': '56.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Computed Tomography Angiography (CTA) Core Laboratory Analysis', 'unitOfMeasure': 'mm2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Aortic Annulus Perimeter', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '74.8', 'spread': '5.0', 'groupId': 'BG000'}, {'value': '75.1', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '75.2', 'spread': '4.9', 'groupId': 'BG002'}, {'value': '75.0', 'spread': '4.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Computed Tomography Angiography (CTA) Core Laboratory Analysis', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Medical History', 'classes': [{'title': 'History of hypertension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '89.4', 'groupId': 'BG000'}, {'value': '88.0', 'groupId': 'BG001'}, {'value': '91.2', 'groupId': 'BG002'}, {'value': '88.9', 'groupId': 'BG003'}]}]}, {'title': 'History of coronary artery disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '52.1', 'groupId': 'BG000'}, {'value': '52.9', 'groupId': 'BG001'}, {'value': '58.1', 'groupId': 'BG002'}, {'value': '53.0', 'groupId': 'BG003'}]}]}, {'title': 'History of myocardial infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'BG000'}, {'value': '7.8', 'groupId': 'BG001'}, {'value': '10.8', 'groupId': 'BG002'}, {'value': '8.4', 'groupId': 'BG003'}]}]}, {'title': 'History of congestive heart failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '31.6', 'groupId': 'BG000'}, {'value': '35.0', 'groupId': 'BG001'}, {'value': '47.3', 'groupId': 'BG002'}, {'value': '34.6', 'groupId': 'BG003'}]}]}, {'title': 'History of atrial fibrillation/atrial flutter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'BG000'}, {'value': '23.4', 'groupId': 'BG001'}, {'value': '34.5', 'groupId': 'BG002'}, {'value': '24.7', 'groupId': 'BG003'}]}]}, {'title': 'Prior pacemaker implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'BG000'}, {'value': '7.0', 'groupId': 'BG001'}, {'value': '11.5', 'groupId': 'BG002'}, {'value': '7.1', 'groupId': 'BG003'}]}]}, {'title': 'History of cerebrovascular accident (TIA & stroke)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'BG000'}, {'value': '11.5', 'groupId': 'BG001'}, {'value': '12.2', 'groupId': 'BG002'}, {'value': '12.3', 'groupId': 'BG003'}]}]}, {'title': 'Current diabetes mellitus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '37.2', 'groupId': 'BG000'}, {'value': '36.2', 'groupId': 'BG001'}, {'value': '42.6', 'groupId': 'BG002'}, {'value': '37.3', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Percentage of participants'}, {'title': 'New York Heart Association (NYHA) Classification', 'classes': [{'title': 'Class I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'BG000'}, {'value': '0.0', 'groupId': 'BG001'}, {'value': '0.0', 'groupId': 'BG002'}, {'value': '0.0', 'groupId': 'BG003'}]}]}, {'title': 'Class II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '50.7', 'groupId': 'BG000'}, {'value': '57.8', 'groupId': 'BG001'}, {'value': '54.7', 'groupId': 'BG002'}, {'value': '54.2', 'groupId': 'BG003'}]}]}, {'title': 'Class III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '47.3', 'groupId': 'BG000'}, {'value': '40.4', 'groupId': 'BG001'}, {'value': '43.9', 'groupId': 'BG002'}, {'value': '43.9', 'groupId': 'BG003'}]}]}, {'title': 'Class IV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'BG000'}, {'value': '1.9', 'groupId': 'BG001'}, {'value': '1.4', 'groupId': 'BG002'}, {'value': '1.9', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'NYHA Classification:\n\nClass I: Subjects with cardiac disease but without resulting limitations of physical activity.\n\nClass I: Subjects with cardiac disease resulting in slight limitation of physical activity.\n\nClass III: Subjects with cardiac disease resulting in marked limitation of physical activity.\n\nClass IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.', 'unitOfMeasure': 'Percentage of participants'}, {'title': 'Operative Risk Group', 'classes': [{'title': 'High/Extreme', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '25.5', 'groupId': 'BG000'}, {'value': '28.6', 'groupId': 'BG001'}, {'value': '33.8', 'groupId': 'BG002'}, {'value': '27.7', 'groupId': 'BG003'}]}]}, {'title': 'Intermediate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '38.6', 'groupId': 'BG000'}, {'value': '36.9', 'groupId': 'BG001'}, {'value': '52.7', 'groupId': 'BG002'}, {'value': '39.1', 'groupId': 'BG003'}]}]}, {'title': 'Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '35.9', 'groupId': 'BG000'}, {'value': '34.5', 'groupId': 'BG001'}, {'value': '13.5', 'groupId': 'BG002'}, {'value': '33.3', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'The subject operative risk is assessed by the site Heart Team and then confirmed by the Case Review Committee who ultimately confirms the subject eligibility for the enrollment in the study.', 'unitOfMeasure': 'Percentage of participants'}, {'title': 'Society of Thoracic Surgeons (STS) Risk Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '1648', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.8', 'groupId': 'BG000'}, {'value': '2.8', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '3.5', 'spread': '2.3', 'groupId': 'BG002'}, {'value': '2.8', 'spread': '1.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "The Society of Thoracic Surgeons Score is a risk model used to predict a subject's risk of mortality and morbidities for the most commonly performed cardiac surgeries. The model is a percentage score from 0 to 100 where a lower score means a lower risk and higher score means a higher risk.", 'unitOfMeasure': 'Percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Aortic Valve Area (AVA)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '724', 'groupId': 'BG000'}, {'value': '716', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '1580', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0.67', 'spread': '0.14', 'groupId': 'BG000'}, {'value': '0.67', 'spread': '0.15', 'groupId': 'BG001'}, {'value': '0.71', 'spread': '0.17', 'groupId': 'BG002'}, {'value': '0.68', 'spread': '0.15', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Transthoracic Echocardiography (TTE) - Core Laboratory Analysis', 'unitOfMeasure': 'cm2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': "Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing."}, {'title': 'Doppler Velocity Index (DVI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '731', 'groupId': 'BG000'}, {'value': '718', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '1591', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.05', 'groupId': 'BG000'}, {'value': '0.24', 'spread': '0.05', 'groupId': 'BG001'}, {'value': '0.24', 'spread': '0.06', 'groupId': 'BG002'}, {'value': '0.24', 'spread': '0.05', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Transthoracic Echocardiography (TTE) - Core Laboratory Analysis\n\nDVI=LVOT Velocity/AV Velocity\n\n* Lower DVI values (\\< 0.25): Suggest severe aortic stenosis. This indicates that the velocity through the LVOT is much lower relative to the high velocity through the stenotic aortic valve.\n* Intermediate values (approximately 0.25-0.50): May indicate moderate stenosis.\n* Higher DVI values (\\> 0.50): Are generally considered normal or only mildly abnormal, indicating minimal obstruction.', 'unitOfMeasure': 'Index', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': "Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing."}, {'title': 'Aortic Valve Mean Pressure Gradient', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '1602', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '39.6', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '39.4', 'spread': '10.5', 'groupId': 'BG001'}, {'value': '38.7', 'spread': '12.0', 'groupId': 'BG002'}, {'value': '39.4', 'spread': '10.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Transthoracic Echocardiography (TTE) - Core Laboratory Analysis', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': "Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing."}, {'title': 'Aortic Valve Peak Velocity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '1602', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4.05', 'spread': '0.54', 'groupId': 'BG000'}, {'value': '4.04', 'spread': '0.51', 'groupId': 'BG001'}, {'value': '3.99', 'spread': '0.57', 'groupId': 'BG002'}, {'value': '4.04', 'spread': '0.53', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Transthoracic Echocardiography (TTE) - Core Laboratory Analysis', 'unitOfMeasure': 'm/s', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': "Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing."}], 'populationDescription': 'Intention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-20', 'size': 2640384, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-24T14:26', 'hasProtocol': True}, {'date': '2023-09-15', 'size': 1148674, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-13T14:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1948}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2018-11-06', 'resultsFirstSubmitDate': '2025-02-24', 'studyFirstSubmitQcDate': '2018-11-07', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-04-09', 'studyFirstPostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definition.'}, {'measure': 'Rate of All Stroke: Disabling and Non-disabling', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definition.'}, {'measure': 'Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure)', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.'}, {'measure': 'Rate of Bleeding: Life-threatening (or Disabling) and Major', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.'}, {'measure': 'Rate of Major Vascular Complications', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.'}, {'measure': 'Rate of Repeat Procedure for Valve-related Dysfunction (Surgical or Interventional Therapy)', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.'}, {'measure': 'Rate of Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure (NYHA Class III or IV)', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.'}, {'measure': 'Rate of New Permanent Pacemaker Implantation (PPI) Resulting From New or Worsened Conduction Disturbances', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.'}, {'measure': 'Rate of New Onset of Atrial Fibrillation or Atrial Flutter', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.'}, {'measure': 'Rate of Acute Kidney Injury (AKI; ≤7 Days Post Index Procedure): Based on the AKIN System Stage 3 (Including Renal Replacement Therapy) or Stage 2', 'timeFrame': 'Participants will be followed peri- and post-procedure, through 7 days post index procedure.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.'}, {'measure': 'Rate of Coronary Obstruction: Periprocedural', 'timeFrame': 'Participants will be followed through 72 hours post index procedure', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) - based on VARC endpoints and definitions.'}, {'measure': 'Rate of Ventricular Septal Perforation: Periprocedural', 'timeFrame': 'Participants will be followed through 72 hours post index procedure', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.'}, {'measure': 'Rate of Mitral Apparatus Damage: Periprocedural', 'timeFrame': 'Participants will be followed through 72 hours post index procedure', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.'}, {'measure': 'Rate of Cardiac Tamponade: Periprocedural', 'timeFrame': 'Participants will be followed through 72 hours post index procedure', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.'}, {'measure': 'Rate of Valve Migration', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.'}, {'measure': 'Rate of Valve Embolization', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.'}, {'measure': 'Rate of Ectopic Valve Deployment', 'timeFrame': 'Participants will be followed peri- and post-procedure through discharge or 7 days post-procedure (whichever comes first).', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.'}, {'measure': 'Rate of Transcatheter Aortic Valve (TAV)-In-TAV Deployment', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.'}, {'measure': 'Rate of Prosthetic Aortic Valve Thrombosis', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.'}, {'measure': 'Rate of Prosthetic Aortic Valve Endocarditis', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.', 'description': 'Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.'}, {'measure': 'Rate of Successful Vascular Access, Delivery and Deployment of the Study Valve, and Successful Retrieval of the Delivery System (Site Reported Assessment)', 'timeFrame': 'Participants will be followed for the duration of their procedure, an expected average of 1 Day (peri- and post-procedure)', 'description': 'Device Performance outcome, as measured by site reported data based on VARC-2 endpoints and definitions.'}, {'measure': 'Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)', 'timeFrame': 'Participants will be assessed pre-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years, 7 years, and 10 years will be posted once data is complete.', 'description': 'Grade of Aortic Regurgitation as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.'}, {'measure': 'Rate of Device Success', 'timeFrame': 'Participants will be followed for the duration of their procedure, an expected average of 1 Day (post-procedure)', 'description': 'Absence of procedural mortality, correct positioning of a single transcatheter valve in the proper anatomical location, and intended performance of the study device (indexed effective orifice area \\[iEOA\\] \\>0.85 cm2/m2 for BMI \\<30 kg/cm2 and iEOA \\>0.70 cm2/m2 for BMI ≥30 kg/cm2 plus either a mean aortic valve gradient \\<20 mmHg or a peak velocity \\< 3m, and no moderate or severe prosthetic valve aortic regurgitation) based on VARC-2 endpoints and definitions.'}, {'measure': 'Effective Orifice Area (EOA)', 'timeFrame': 'Participants will be assessed pre-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years, 7 years, and 10 years will be posted once data is complete.', 'description': 'Effective Orifice Area (EOA), as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory'}, {'measure': 'Mean Aortic Gradient', 'timeFrame': 'Participants will be assessed pre-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years, 7 years, and 10 years will be posted once data is complete.', 'description': 'Mean Aortic Gradient as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.'}, {'measure': 'New York Heart Association (NYHA) Functional Status Classification', 'timeFrame': 'Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years, 7 years, and 10 years will be posted once data is complete.', 'description': 'Health status evaluated by New York Heart Association (NYHA) Classification.\n\nNYHA Classification:\n\nClass I: Subjects with cardiac disease but without resulting limitations of physical activity.\n\nClass I: Subjects with cardiac disease resulting in slight limitation of physical activity.\n\nClass III: Subjects with cardiac disease resulting in marked limitation of physical activity.\n\nClass IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.'}, {'measure': 'Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Assessment - Change From Baseline', 'timeFrame': 'Participants will be assessed at baseline, 30 Days, and 1 Year. Data for 5 years will be posted once data is complete.', 'description': 'Health Status additional outcome KCCQ Analysis - Overall Summary Score change from Baseline.\n\nKansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.\n\nOverall Summary Score - mean of score 1, 5, 7, and 8'}, {'measure': 'Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline', 'timeFrame': 'Participants will be assessed at baseline, 30 Days, and 1 Year. Data for 5 years will be posted once data is complete.', 'description': 'Health Status outcome - SF-12 - Baseline scores and changes from Baseline at 30 Days and 1 Year.\n\n12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.'}], 'primaryOutcomes': [{'measure': 'Composite Rate of All-cause Mortality, All Stroke, and Rehospitalization* at 1 Year in the Main Randomized Cohort.', 'timeFrame': 'Participants will be followed for the duration of hospital stay through 1 year.', 'description': 'Primary Endpoint: A Clinical Events Committee (CEC), independent group of physician experts reviewed and adjudicated all reported cases of death, stroke and rehospitalization to determine whether they met the specific protocol definition of the event. The CEC adjudicated results are used in the endpoint analysis.\n\n\\* Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV); per VARC-2 definition.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Aortic Stenosis']}, 'referencesModule': {'references': [{'pmid': '40406945', 'type': 'BACKGROUND', 'citation': 'Makkar RR, Chakravarty T, Gupta A, Soliman O, Gnall E, Ramana RK, Ramlawi B, Diamantouros P, Potluri S, Kleiman NS, Samy S, Rassi A, Yadav P, Thourani V, Yakubov S, Frawley C, Patel D, Kapadia S, Chalekian A, Modolo R, Sathananthan J, Kim WK, Reardon MJ. Valve Underexpansion and Clinical Outcomes With ACURATE neo2: Findings From the ACURATE IDE Trial. J Am Coll Cardiol. 2025 Jul 29;86(4):225-238. doi: 10.1016/j.jacc.2025.05.011. Epub 2025 May 21.'}, {'pmid': '40412426', 'type': 'RESULT', 'citation': 'Makkar RR, Ramana RK, Gnall E, Ramlawi B, Cheng W, Diamantouros P, Potluri S, Kleinman N, Gupta A, Chakravarty T, Samy S, Rassi A, Rajagopal V, Yakubov S, Sorajja P, Patel D, Garcia S, Yadav P, Thourani V, Wang J, Rinaldi M, Kapadia S, Waksman R, Webb J, Ren CB, Gregson J, Modolo R, Sathananthan J, Reardon MJ; ACURATE IDE study investigators. ACURATE neo2 valve versus commercially available transcatheter heart valves in patients with severe aortic stenosis (ACURATE IDE): a multicentre, randomised, controlled, non-inferiority trial. Lancet. 2025 Jun 7;405(10494):2061-2074. doi: 10.1016/S0140-6736(25)00319-8. Epub 2025 May 21.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.\n\nAs of 28-May-2025, Boston Scientific Corporation (BSC) announced the voluntary global discontinuation of the ACURATE product platform, including both the ACURATE neo2 and ACURATE Prime Aortic Valve Systems. BSC will no longer pursue regulatory approval for the device in the U.S. or other unapproved geographies.', 'detailedDescription': 'Subjects will be enrolled at up to 85 centers in the United States, Canada, Europe, and Australia. There will be up to 2,820 subjects in ACURATE IDE.\n\nThe ACURATE IDE study cohorts include the following.\n\n* Main Randomized Cohort: A prospective, multicenter, 1:1 randomized controlled trial (RCT; ACURATE versus a commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration \\[SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA\\] or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration \\[CoreValve; Medtronic, Inc., Dublin, Ireland\\]). There will be up to 1,500 subjects in the RCT.\n* Roll-In Cohort: A non-randomized roll-in phase with the test device. Centers that do not have implantation experience with the ACURATE neo™ Aortic Bioprosthesis (transfemoral delivery; Boston Scientific Corporation, Marlborough, MA, USA) will perform at least 2 roll-in cases before commencing treatment in the randomized cohort. Centers with prior experience with ACURATE are not required to do roll-in cases. Data from roll-in subjects will be summarized separately from the randomized cohort and will not be included in the primary endpoint analysis.\n* 4D CT Imaging Substudy: Selected centers with the ability to perform high quality 4D computer tomography (CT) scans will include subjects in a 4D CT Imaging Substudy to assess the prevalence of reduced leaflet mobility and hypoattenuated leaflet thickening (HALT) and the relationship, if any, to clinical events. Subjects will be randomized to test (ACURATE) and control device.\n* ACURATE Prime™ XL Nested Registry: A non-randomized, nested registry cohort of subjects who will receive the ACURATE Prime™ Transfemoral Aortic Valve System XL (ACURATE Prime XL Nested Registry). Participating centers will be a subset of United States centers that have enrolled subjects in ACURATE IDE. Data from subjects in this nested registry will be summarized separately from the randomized and roll-in cohorts.\n* ACURATE Extended Durability Study: An additional 1:1 randomized study (ACURATE versus a commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration \\[SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA\\] or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration \\[CoreValve; Medtronic, Inc., Dublin, Ireland\\]) including only subjects considered to be at low surgical risk. Subjects will receive ACURATE neo2 (S, M, or L valve sizes) or ACURATE Prime XL. Data from subjects in the Extended Durability Study will be summarized separately from other cohorts.\n* ACURATE Continued Access Study (CAS): An additional cohort of subjects receiving ACURATE neo2 (S, M, and L valve sizes) or ACURATE Prime XL. Data from subjects in the ACURATE CAS will be summarized separately from other cohorts and will be used to further assess performance and safety.\n\nFollow-up\n\n* Subjects implanted with a test device will be assessed at baseline, peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, 1 year, and then annually for 5 years post-procedure.\n* Subjects implanted with a control device will be assessed at baseline, peri- and post-procedure, at discharge or 7 days post procedure (whichever comes first), 30 days, 6 months, and 1 year post procedure. Per protocol, no additional follow-up is required beyond this period, and standard of care practices will apply.\n* Some subjects may have completed additional annual follow-up visits based on requirements outlined in earlier versions of the protocol.\n* Subjects who are enrolled but not implanted with a test or control device at the time of the procedure will be followed for safety through 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* IC1. Subject has documented severe symptomatic native aortic stenosis defined as follows: aortic valve area (AVA) ≤1.0 cm2 (or AVA index ≤0.6 cm2/m2) AND a mean pressure gradient ≥40 mmHg, OR maximal aortic valve velocity ≥4.0 m/s, OR Doppler velocity index ≤0.25 as measured by echocardiography and/or invasive hemodynamics.\n\nNote: In cases of low flow, low gradient aortic stenosis with left ventricular dysfunction (ejection fraction \\<50%), dobutamine can be used to assess the grade of aortic stenosis (maximum dobutamine dose of 20 mcg/kg/min recommended); the subject may be enrolled if echocardiographic criteria are met with this augmentation.\n\n* IC2. Subject has a documented aortic annulus size of ≥20.5 mm and ≤29 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee \\[CRC\\]) and, for the Main Randomized Cohort and the Extended Durability Study, is deemed treatable with an available size of both test and control device.\n* IC3. For subjects with symptomatic aortic valve stenosis per IC1 definition above, functional status is NYHA Functional Class ≥ II.\n* IC4. Heart team (which must include an experienced cardiac interventionalist and an experienced cardiac surgeon) agrees that the subject is indicated for TAVR, is likely to benefit from valve replacement, and TAVR is appropriate.\n* IC5. Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent.\n* IC6. Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow up visits.\n* IC7. Subject is expected to be able to take the protocol-required adjunctive pharmacologic therapy.\n\nExclusion Criteria:\n\n* EC1. Subject has a unicuspid or bicuspid aortic valve.\n* EC2. Subject has had an acute myocardial infarction within 30 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin elevation).\n* EC3. Subject has had a cerebrovascular accident or transient ischemic attack clinically confirmed by a neurologist or neuroimaging within the past 6 months prior to study enrollment.\n* EC4. Subject is on renal replacement therapy or has eGFR \\<20.\n* EC5. Subject has a pre-existing prosthetic aortic or mitral valve.\n* EC6. Subject has severe (4+) aortic, tricuspid, or mitral regurgitation.\n* EC7. Subject has moderate or severe mitral stenosis (mitral valve area ≤1.5 cm2 and diastolic pressure half-time ≥150 ms, Stage C or D76).\n* EC8. Subject has a need for emergency surgery for any reason.\n* EC9. Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis.\n* EC10. Subject has echocardiographic evidence of new intra-cardiac vegetation or intraventricular or paravalvular thrombus requiring intervention.\n* EC11. Subject has platelet count \\<50,000 cells/mm3 or \\>700,000 cells/mm3, or white blood cell count \\<1,000 cells/mm3.\n* EC12. Subject has had a gastrointestinal bleed requiring hospitalization or transfusion within the past 3 months, or has other clinically significant bleeding diathesis or coagulopathy that would preclude treatment with required antiplatelet regimen, or will refuse transfusions.\n* EC13. Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to the protocol required medications (aspirin, all P2Y12 inhibitors, heparin), or to the individual components of the test or control valve (nickel, titanium, stainless steel, platinum, iridium or polyethylene terephthalate \\[PET\\]).\n* EC14. Subject has a life expectancy of less than 12 months due to non-cardiac, comorbid conditions based on the assessment of the investigator at the time of enrollment.\n* EC15. Subject has hypertrophic cardiomyopathy.\n* EC16. Subject has any therapeutic invasive cardiac or vascular procedure within 30 days prior to the index procedure (except for balloon aortic valvuloplasty, pacemaker implantation, or implantable cardioverter defibrillator implantation, which are allowed).\n* EC17. Subject has untreated coronary artery disease, which in the opinion of the treating physician is clinically significant and requires revascularization.\n* EC18. Subject has severe left ventricular dysfunction with ejection fraction \\<20%.\n* EC19. Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.\n* EC20. Subject has arterial access that is not acceptable for the study device (test or control) delivery systems as defined in the device (test or control) Directions For Use.\n* EC21. Subject has either of the following:\n\n * Severe vascular disease that would preclude safe access (e.g., aneurysm with thrombus that cannot be crossed safely; marked tortuosity; significant narrowing of the abdominal aorta; severe unfolding of the thoracic aorta; or thick, protruding, ulcerated atheroma in the aortic arch), OR\n * Severe/eccentric calcification of the aortic annulus that would prevent safe implantation of the TAVR prosthesis.\n* EC22. Subject has current problems with substance abuse (e.g., alcohol, etc.) that may interfere with the subject's participation in this study.\n* EC23. Subject is participating in another investigational drug or device study that has not reached its primary endpoint or subject intends to participate in another investigational device clinical trial within 12 months after index procedure.\n* EC24. Subject has untreated conduction system disorder (e.g., Type II second degree atrioventricular block) that in the opinion of the treating physician is clinically significant and requires a pacemaker implantation. Enrollment is permissible after permanent pacemaker implantation.\n* EC25. Subject has severe incapacitating dementia.\n\nAdditional exclusion criteria apply to subjects considered for enrollment in the CT Imaging Substudy as listed below.\n\n* AEC1. Subject has eGFR \\<30 mL/min (chronic kidney disease stage IV or stage V)\n* AEC2. Subject has atrial fibrillation that cannot be rate controlled to ventricular response rate \\< 60 bpm.\n* AEC3. Subject is expected to undergo chronic anticoagulation therapy after the index procedure.\n\nNote: Subjects treated with short-term anticoagulation post procedure can be included in the CT Imaging Substudy; in these subjects the 30-day imaging will be performed 30 days after discontinuation of anticoagulation."}, 'identificationModule': {'nctId': 'NCT03735667', 'briefTitle': 'ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'ACURATE IDE: Transcatheter Replacement of Stenotic Aortic Valve Through Implantation of ACURATE in Subjects InDicatEd for TAVR', 'orgStudyIdInfo': {'id': 'S2408'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACURATE Valve - Main Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.\n\n\\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.', 'interventionNames': ['Device: ACURATE neo2™ Transfemoral TAVR System']}, {'type': 'EXPERIMENTAL', 'label': 'ACURATE Valve - Single-arm Roll-in', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.', 'interventionNames': ['Device: ACURATE neo2™ Transfemoral TAVR System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Commercial Valve - Main Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.\n\n\\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.', 'interventionNames': ['Device: Medtronic CoreValve TAVR System', 'Device: Edwards SAPIEN 3 TAVR System']}, {'type': 'EXPERIMENTAL', 'label': 'ACURATE Valve - Single-arm Prime XL', 'description': 'Patients assigned to this group will be implanted with ACURATE Prime™ transfemoral TAVR System XL.\n\n\\*50 subjects will be enrolled in the Prime™ XL Nested Registry', 'interventionNames': ['Device: ACURATE Prime™ Transfemoral TAVR System XL']}, {'type': 'EXPERIMENTAL', 'label': 'ACURATE Valve - Extended Durability Randomized', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System (S, M, L) or ACURATE Prime™ transfemoral TAVR System XL. Only low risk patients are enrolled in this group.', 'interventionNames': ['Device: ACURATE neo2™ Transfemoral TAVR System', 'Device: ACURATE Prime™ Transfemoral TAVR System XL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Commercial Valve - Extended Durability Randomized', 'description': 'Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System\n\nPatients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. Only low risk patients are enrolled in this group.', 'interventionNames': ['Device: Medtronic CoreValve TAVR System', 'Device: Edwards SAPIEN 3 TAVR System']}, {'type': 'EXPERIMENTAL', 'label': 'ACURATE Valve - Continued Access Study', 'description': 'Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System (S, M, L) or ACURATE Prime™ transfemoral TAVR System XL.', 'interventionNames': ['Device: ACURATE neo2™ Transfemoral TAVR System', 'Device: ACURATE Prime™ Transfemoral TAVR System XL']}], 'interventions': [{'name': 'ACURATE neo2™ Transfemoral TAVR System', 'type': 'DEVICE', 'description': 'ACURATE neo2™ Transfemoral TAVR system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to limit paravalvular regurgitation (manufactured by Boston Scientific Corporation, Marlborough, MA, USA).', 'armGroupLabels': ['ACURATE Valve - Continued Access Study', 'ACURATE Valve - Extended Durability Randomized', 'ACURATE Valve - Main Randomized', 'ACURATE Valve - Single-arm Roll-in']}, {'name': 'Medtronic CoreValve TAVR System', 'type': 'DEVICE', 'description': 'Medtronic CoreValve Evolut R or Evolut PRO Transcatheter Aortic Valve Replacement (TAVR) System (or any future Corevalve iterations): The support frame is manufactured from nitinol, which has multilevel, self-expanding properties and is radiopaque. The bioprosthesis is manufactured by suturing valve leaflets and a skirt from porcine pericardium into a tri-leaflet configuration (manufactured by Medtronic CoreValve LLC, Santa Ana, USA).', 'armGroupLabels': ['Commercial Valve - Extended Durability Randomized', 'Commercial Valve - Main Randomized']}, {'name': 'Edwards SAPIEN 3 TAVR System', 'type': 'DEVICE', 'description': 'Edwards SAPIEN 3 TAVR system (or any future SAPIEN iterations): balloon-expandable transcatheter aortic bioprosthesis, support frame made of cobalt-chromium, three leaflets constructed of processed bovine pericardial tissue and an outer polyethylene terephthalate (PET) sealing cuff to mitigate paravalvular regurgitation (manufactured by Edwards Lifesciences, Inc., Irvine, California, USA)', 'armGroupLabels': ['Commercial Valve - Extended Durability Randomized', 'Commercial Valve - Main Randomized']}, {'name': 'ACURATE Prime™ Transfemoral TAVR System XL', 'type': 'DEVICE', 'description': 'ACURATE Prime™ Transfemoral TAVR system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to limit paravalvular regurgitation (manufactured by Boston Scientific Corporation, Marlborough, MA, USA).', 'armGroupLabels': ['ACURATE Valve - Continued Access Study', 'ACURATE Valve - Extended Durability Randomized', 'ACURATE Valve - Single-arm Prime XL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Good Samaritan', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'HonorHealth Scottsdale Healthcare', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'TMC HealthCare', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Baptist Health Medical Center', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Heart Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente - 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