Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-01-24 @ 11:12 PM
Study NCT ID:
NCT03752866
Status:
COMPLETED
Last Update Posted:
2024-10-21
First Post:
2018-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'vinny.podichetty@abbott.com', 'phone': '+1 408-845-1639', 'title': 'Vinny Podichetty, Sr. Director, Global Clinical Affairs', 'organization': 'Abbott'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '30 days', 'description': 'The adverse event data were collected for 30 days. However, the all-Cause mortality was assessed for up to 12 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.', 'otherNumAtRisk': 501, 'deathsNumAtRisk': 501, 'otherNumAffected': 72, 'seriousNumAtRisk': 501, 'deathsNumAffected': 16, 'seriousNumAffected': 348}, {'id': 'EG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.', 'otherNumAtRisk': 500, 'deathsNumAtRisk': 500, 'otherNumAffected': 80, 'seriousNumAtRisk': 500, 'deathsNumAffected': 10, 'seriousNumAffected': 358}], 'otherEvents': [{'term': 'Left Bundle Branch Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 80}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Aortic Valve Regurgitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardiac Arrhythmias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardiogenic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Complete Heart Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 49}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Congestive Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Death - Unknown', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'First Degree Heart Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Left Bundle Branch Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Mitral Valve Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myocardial Ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 32}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Paravalvular Leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pericardial Tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Second Degree Heart Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thrombus On Device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Valve Embolization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ventricular Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'GI Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Death - Unknown', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Multi Organ Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Death - Unknown', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Multi Organ Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal Insufficiency/Worsening Renal Function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urinary Tract Infection/UTI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Annulus Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Valve Embolization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Valve Migration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Death - Unknown', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Death - Unknown', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Transient Ischemic Attack (TIA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Multi Organ Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal Insufficiency/Worsening Renal Function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Access Site Bleeding Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Death - Unknown', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vascular Access Site And Access Related Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vascular Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vascular Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vessel Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 500, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cardiovascular Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.'}, {'id': 'OG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days from the index procedure', 'description': 'Death due to proximate cardiac cause, non-coronary vascular conditions, procedure-related deaths, valve-related deaths, sudden or unwitnessed death and unknown cause.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed includes subjects who were available at that time of analysis'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.'}, {'id': 'OG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.'}, {'id': 'OG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.'}], 'classes': [{'title': 'Disabling Stroke', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Non-Disabling Stroke', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Bleeding Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.'}, {'id': 'OG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.'}], 'classes': [{'title': 'Life Threatening', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Major', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Minor', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Acute Kidney Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.'}, {'id': 'OG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.'}], 'classes': [{'title': 'Stage 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Stage 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Stage 3', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 30 days', 'description': 'The increase in creatinine must occur within 48 hours.\n\nStage 1: Increase in serum creatinine to 150% to 199% (1.5 to 1.99 X increase compared with baseline) or increase of greater than or equal to 0.3 mg/dL (26.4 mmol/L) or Urine output \\<0.5 mL/kg per hour for \\>6 but \\<12 hours.\n\nStage 2: Increase in serum creatinine to 200% to 299% (2.0 to 2.99 X increase compared with baseline) or Urine output \\<0.5 mL/kg per hour for \\>12 but \\<24 hours.\n\nStage 3: Increase in serum creatinine to greater than or equal to 300% (3 X increase compared with baseline) or serum creatinine of ≥ 4.0 mg/dL (354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)or Urine output \\<0.3 mL/kg per hour for ≥24 hours or anuria for ≥12 hours. Patients receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Vascular Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.'}, {'id': 'OG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.'}], 'classes': [{'title': 'Major', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Minor', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Annular Rupture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.'}, {'id': 'OG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Coronary Obstruction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.'}, {'id': 'OG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Undergoing Conversion To Open Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.'}, {'id': 'OG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number Of Subjects Undergoing Transcatheter Valve-In-Valve Deployment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.'}, {'id': 'OG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number Of Subjects With Valve Embolization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.'}, {'id': 'OG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number Of Subjects Undergoing Naïve Permanent Pacemaker Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '454', 'groupId': 'OG000'}, {'value': '444', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.'}, {'id': 'OG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with a pacemaker at baseline are not included.'}, {'type': 'SECONDARY', 'title': 'Vessel Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '499', 'groupId': 'OG000'}, {'value': '497', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.'}, {'id': 'OG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.42', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '7.09', 'spread': '1.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 30 days', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Introducer Sheath Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.'}, {'id': 'OG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.'}], 'classes': [{'categories': [{'measurements': [{'value': '469', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 30 days', 'description': 'This is a yes or no question on the CRF. Sites report if the implanter used an introducer sheath (a special device used to facilitate introduction of the investigational device into the subjects vasculature).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Implant Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.'}, {'id': 'OG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.'}], 'classes': [{'categories': [{'measurements': [{'value': '488', 'groupId': 'OG000'}, {'value': '488', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Effective Orifice Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.'}, {'id': 'OG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.85', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '1.80', 'spread': '0.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 30 days', 'description': 'Effective orifice area is a measure of the working area of the implanted valve determined by echocardiograph.', 'unitOfMeasure': 'cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aortic Valve Mean Gradient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '404', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.'}, {'id': 'OG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.38', 'spread': '4.44', 'groupId': 'OG000'}, {'value': '6.80', 'spread': '2.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 30 days', 'description': 'Aortic valve mean gradient is a measure of the pressure gradient across the aortic valve measured by echocardiograph.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Paravalvular Leak (PVL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '386', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.'}, {'id': 'OG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.'}], 'classes': [{'title': 'None/Trace/Trivial', 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'NYHA Classification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '457', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.'}, {'id': 'OG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.'}], 'classes': [{'title': 'NYHA I', 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}]}, {'title': 'NYHA II', 'categories': [{'measurements': [{'value': '218', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}]}, {'title': 'NYHA III', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'NYHA IV', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 30 days', 'description': "NYHA Functional Classification is a system used to assess patient heart failure severity based on their limitations of physical activity. The four classes are described below:\n\nClass I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or shortness of breath.\n\nClass II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain.\n\nClass III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.\n\nClass IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort.\n\nSubjects' NYHA Classification based on above criteria was assessed during follow up, and subjects were assigned to one of four classifications. Results are presented as percentage of all available subjects who were assigned each functional class (I-IV).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'EQ5D-3L Visual Analog Scale Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.'}, {'id': 'OG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.5', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '66.0', 'spread': '18.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 30 days', 'description': 'The EQ-5D-3L consists of EuroQoL 5 questions and 3 answering levels. The rating of questions includes: Level 1 no problems; Level 2 some problems; Level 3 Significant problems; Worst case is 15 points; and best case is 5 points using index. The Visual analogue scale VAS 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Rate of All-cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.'}, {'id': 'OG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000'}, {'value': '11.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 12 months', 'description': 'Kaplan-Meier (KM) percentage of subjects who died. KM is a statistical method that attempts to account for other factors that may have reduced the number of subjects evaluable at a given time point.', 'unitOfMeasure': 'percentage of All-cause Mortality', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.'}, {'id': 'FG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '501'}, {'groupId': 'FG001', 'numSubjects': '500'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '501'}, {'groupId': 'FG001', 'numSubjects': '500'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Between October 2018 and July 2021, implantation with a Portico™ transcatheter heart valve (THV) was attempted in 1001 subjects. This clinical investigation includes 27 sites in 8 countries across Europe and 1 site in Australia.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '1001', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.'}, {'id': 'BG001', 'title': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems. Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '1001', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '81.7', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '82.3', 'spread': '5.3', 'groupId': 'BG001'}, {'value': '82.0', 'spread': '5.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '1001', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '319', 'groupId': 'BG000'}, {'value': '307', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '193', 'groupId': 'BG001'}, {'value': '375', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '1001', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Czechia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '1001', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '1001', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '1001', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '1001', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '1001', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Switzerland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '1001', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '1001', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '272', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '467', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '1001', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '1001', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '440', 'groupId': 'BG000'}, {'value': '431', 'groupId': 'BG001'}, {'value': '871', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'NYHA Classification', 'classes': [{'title': 'NYHA I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '1001', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'NYHA II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '1001', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}]}]}, {'title': 'NYHA III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '1001', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '295', 'groupId': 'BG000'}, {'value': '293', 'groupId': 'BG001'}, {'value': '588', 'groupId': 'BG002'}]}]}, {'title': 'NYHA IV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '500', 'groupId': 'BG001'}, {'value': '1001', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'New York Heart Association heart failure classification. I - no symptoms and no limitation. II - mild symptoms. III - marked limitation in activity due to symptoms, even during less-than-ordinary activity.\n\nIV - severe limitation, experiences symptoms even at rest.', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline EQ5D-3L Visual Analog Scale Value', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'BG000'}, {'value': '458', 'groupId': 'BG001'}, {'value': '864', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60.8', 'spread': '18.5', 'groupId': 'BG000'}, {'value': '60.1', 'spread': '17.8', 'groupId': 'BG001'}, {'value': '60.4', 'spread': '18.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'EQ5D-3L stands for EuroQol5D-3L. Scale 0-100 (best). Subject selects their rating of their own health on a visual scale from 0-100.\n\nScores were used as a measure of improvement from baseline; subjects served as their own controls. Staging was relative to the unitless baseline score - higher score was better.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The number analyzed in row differs because not all subjects had EQ5D-3L collected at baseline.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-08', 'size': 21193058, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-10-07T06:02', 'hasProtocol': True}, {'date': '2021-06-23', 'size': 3267953, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-10-06T04:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This registry will include market released Portico™ valves (23mm, 25mm, 27mm and 29mm), delivery systems and loading systems. The registry will also allow future iterations of the Portico valve and delivery system along with expanded indications to be included as they receive approval for commercial use in the country where the subject is enrolled.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1001}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-18', 'studyFirstSubmitDate': '2018-11-15', 'resultsFirstSubmitDate': '2023-10-19', 'studyFirstSubmitQcDate': '2018-11-23', 'lastUpdatePostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-18', 'studyFirstPostDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular Mortality', 'timeFrame': '30 days from the index procedure', 'description': 'Death due to proximate cardiac cause, non-coronary vascular conditions, procedure-related deaths, valve-related deaths, sudden or unwitnessed death and unknown cause.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Myocardial Infarction', 'timeFrame': 'At 30 days'}, {'measure': 'Number of Subjects With Stroke', 'timeFrame': 'At 30 days'}, {'measure': 'Number of Subjects With Bleeding Events', 'timeFrame': 'At 30 days'}, {'measure': 'Number of Subjects With Acute Kidney Injury', 'timeFrame': 'At 30 days', 'description': 'The increase in creatinine must occur within 48 hours.\n\nStage 1: Increase in serum creatinine to 150% to 199% (1.5 to 1.99 X increase compared with baseline) or increase of greater than or equal to 0.3 mg/dL (26.4 mmol/L) or Urine output \\<0.5 mL/kg per hour for \\>6 but \\<12 hours.\n\nStage 2: Increase in serum creatinine to 200% to 299% (2.0 to 2.99 X increase compared with baseline) or Urine output \\<0.5 mL/kg per hour for \\>12 but \\<24 hours.\n\nStage 3: Increase in serum creatinine to greater than or equal to 300% (3 X increase compared with baseline) or serum creatinine of ≥ 4.0 mg/dL (354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)or Urine output \\<0.3 mL/kg per hour for ≥24 hours or anuria for ≥12 hours. Patients receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria.'}, {'measure': 'Number of Subjects With Vascular Complications', 'timeFrame': 'At 30 days'}, {'measure': 'Number of Subjects With Annular Rupture', 'timeFrame': 'At 30 days'}, {'measure': 'Number of Subjects With Coronary Obstruction', 'timeFrame': 'At 30 days'}, {'measure': 'Number of Subjects Undergoing Conversion To Open Surgery', 'timeFrame': 'At 30 days'}, {'measure': 'Number Of Subjects Undergoing Transcatheter Valve-In-Valve Deployment', 'timeFrame': 'At 30 days'}, {'measure': 'Number Of Subjects With Valve Embolization', 'timeFrame': 'At 30 days'}, {'measure': 'Number Of Subjects Undergoing Naïve Permanent Pacemaker Insertion', 'timeFrame': 'At 30 days'}, {'measure': 'Vessel Diameter', 'timeFrame': 'At 30 days'}, {'measure': 'Introducer Sheath Used', 'timeFrame': 'At 30 days', 'description': 'This is a yes or no question on the CRF. Sites report if the implanter used an introducer sheath (a special device used to facilitate introduction of the investigational device into the subjects vasculature).'}, {'measure': 'Implant Success', 'timeFrame': 'At 30 days'}, {'measure': 'Effective Orifice Area', 'timeFrame': 'At 30 days', 'description': 'Effective orifice area is a measure of the working area of the implanted valve determined by echocardiograph.'}, {'measure': 'Aortic Valve Mean Gradient', 'timeFrame': 'At 30 days', 'description': 'Aortic valve mean gradient is a measure of the pressure gradient across the aortic valve measured by echocardiograph.'}, {'measure': 'Number of Subjects With Paravalvular Leak (PVL)', 'timeFrame': 'At 30 days'}, {'measure': 'NYHA Classification', 'timeFrame': 'At 30 days', 'description': "NYHA Functional Classification is a system used to assess patient heart failure severity based on their limitations of physical activity. The four classes are described below:\n\nClass I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or shortness of breath.\n\nClass II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain.\n\nClass III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.\n\nClass IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort.\n\nSubjects' NYHA Classification based on above criteria was assessed during follow up, and subjects were assigned to one of four classifications. Results are presented as percentage of all available subjects who were assigned each functional class (I-IV)."}, {'measure': 'EQ5D-3L Visual Analog Scale Value', 'timeFrame': 'At 30 days', 'description': 'The EQ-5D-3L consists of EuroQoL 5 questions and 3 answering levels. The rating of questions includes: Level 1 no problems; Level 2 some problems; Level 3 Significant problems; Worst case is 15 points; and best case is 5 points using index. The Visual analogue scale VAS 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state."'}, {'measure': 'Kaplan-Meier Rate of All-cause Mortality', 'timeFrame': 'At 12 months', 'description': 'Kaplan-Meier (KM) percentage of subjects who died. KM is a statistical method that attempts to account for other factors that may have reduced the number of subjects evaluable at a given time point.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Portico™ valve', 'Portico™ valve delivery system', 'Portico™ valve loading system', 'Transcatheter Aortic Valve Replacement', 'Aortic Stenosis', 'Heart Valve Prosthesis', 'TAVR', 'TAVR Registry', 'Transcatheter Aortic Valve Implant', 'TAVI', 'TAVI Registry', 'FlexNav delivery system', 'FlexNav loading system'], 'conditions': ['Symptomatic Degenerative Aortic Stenosis', 'Severe Aortic Stenosis']}, 'referencesModule': {'references': [{'pmid': '38283573', 'type': 'DERIVED', 'citation': 'Mollmann H, Linke A, Nombela-Franco L, Sluka M, Francisco Oteo Dominguez J, Montorfano M, Kim WK, Arnold M, Vasa-Nicotera M, Fichtlscherer S, Conradi L, Camuglia A, Bedogni F, Kohli K, Manoharan G. Valve Hemodynamics by Valve Size and 1-Year Survival Following Implantation of the Portico Valve in the Multicenter CONFIDENCE Registry. Struct Heart. 2023 Nov 11;8(1):100226. doi: 10.1016/j.shj.2023.100226. eCollection 2024 Jan.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative aortic stenosis.', 'detailedDescription': 'The CONFIDENCE registry study will be conducting as a prospective, non-randomized, observational, single-arm, multi-center study.\n\nApproximately 1000 subjects with severe symptomatic (NYHA class ≥ II) aortic stenosis (AS), will undergo Portico™ Transcatheter Aortic Heart Valve implantation.\n\nThe subject data will be collected at baseline, index procedure, pre- discharge, 30 days and 12 months from the index procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects who are ≥18 years of age or legal age in host country and have been identified as a candidate for a Portico™ valve implant\n2. Subjects who have been informed of the nature of the study, agree to its provisions and have provided written informed consent as approved by the Ethics Committee (EC) of the respective clinical center\n\nExclusion Criteria:\n\n1. Have sepsis, including active endocarditis\n2. Have any evidence of left ventricular or atrial thrombus\n3. Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable\n4. Have a non-calcified aortic annulus\n5. Have congenital bicuspid or unicuspid leaflet configuration\n6. Are unable to tolerate antiplatelet/anticoagulant therapy\n7. Are pregnant at the time of signing informed consent\n8. Are currently participating in a drug or device study that may impact the registry (unless prior sponsor approval for co-enrollment is granted)'}, 'identificationModule': {'nctId': 'NCT03752866', 'briefTitle': 'CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'CONtrolled Delivery For ImproveD outcomEs With cliNiCal Evidence', 'orgStudyIdInfo': {'id': 'SJM-CIP-CL1003491'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Portico™ Valve, Delivery System(s) and Loading System(s)', 'description': 'Subjects undergoing implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system will be included.', 'interventionNames': ['Device: Portico™ Valve, Portico Delivery System(s) and Loading System(s)']}, {'type': 'EXPERIMENTAL', 'label': 'Portico™ Valve, FlexNav Delivery and Loading System(s)', 'description': 'Subjects undergoing implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems will be included.', 'interventionNames': ['Device: Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)']}], 'interventions': [{'name': 'Portico™ Valve, Portico Delivery System(s) and Loading System(s)', 'type': 'DEVICE', 'description': 'Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.', 'armGroupLabels': ['Portico™ Valve, Delivery System(s) and Loading System(s)']}, {'name': 'Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)', 'type': 'DEVICE', 'description': 'Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.', 'armGroupLabels': ['Portico™ Valve, FlexNav Delivery and Loading System(s)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Heart Care Partners- Wesley Hospital', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'AZ Middelheim', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '77900', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'University Hospital Olomouc', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '91054', 'city': 'Erlangen', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Kliniken der Friedrich-Alexander-Universitat', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '61231', 'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Kerckhoff-Klinik gGmbH', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Universitätsmedizin Berlin - Charité Campus Mitte (CCM)', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12203', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44137', 'city': 'Dortmund', 'country': 'Germany', 'facility': 'St.-Johannes-Hospital', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Herzzentrum Dresden GmbH Universitätsklinik', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Klinikum der Johann Wolfgang Goethe-Universität Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'UKE Hamburg (Universitatsklinik Eppendorf)', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '76133', 'city': 'Karlsruhe', 'country': 'Germany', 'facility': 'Städtisches Klinikum Karlsruhe gGmbH Medizinischen Klinik IV', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Universitätsmedizin der Johannes Gutenberg-Universität Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '13353', 'city': 'Mitte', 'country': 'Germany', 'facility': 'Charite Campus Virchow Klinikum', 'geoPoint': {'lat': 52.52003, 'lon': 13.40489}}, {'zip': '20900', 'city': 'Monza', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Policlinico di Monza', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20097', 'city': 'San Donato Milanese', 'country': 'Italy', 'facility': 'Policlinico San Donato', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}, {'zip': '36100', 'city': 'Vicenza', 'country': 'Italy', 'facility': 'Ospedale San Bortolo', 'geoPoint': {'lat': 45.54672, 'lon': 11.5475}}, {'zip': '02-097', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Centralny Szpital Kliniczny', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '08025', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu I Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '21005', 'city': 'Huelva', 'country': 'Spain', 'facility': 'Hospital General Juan Ramon Jimenez', 'geoPoint': {'lat': 37.26638, 'lon': -6.94004}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28222', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta de Hierro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '5001', 'city': 'Aarau', 'country': 'Switzerland', 'facility': 'Kantonsspital Aarau', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}, {'zip': 'BT12 6BA', 'city': 'Belfast', 'state': 'Ireland', 'country': 'United Kingdom', 'facility': 'Royal Victoria Hospital', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'TS4 3BW', 'city': 'Middlesbrough', 'state': 'North East England', 'country': 'United Kingdom', 'facility': 'James Cook University Hoospital', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}, {'zip': 'SA6 6NL', 'city': 'Morriston', 'state': 'Swansea', 'country': 'United Kingdom', 'facility': 'Morriston Hospital - ABM University Health Board', 'geoPoint': {'lat': 51.66995, 'lon': -3.92941}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Helge Möllmann', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Johannes Hospital, Dortmund, Germany'}, {'name': 'Vinny Podichetty', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Structural Heart'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}