Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
Study NCT ID:
NCT00354159
Status:
COMPLETED
Last Update Posted:
2012-08-09
First Post:
2006-07-19
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (HF) (REDUCEhf)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medtronicCRMtrials@medtronic.com', 'phone': '1-800-328-2518', 'title': 'REDUCEhf Clinical Research Specialist', 'phoneExt': '62736', 'organization': 'Medtronic CRDM'}, 'certainAgreement': {'otherDetails': 'Generally, contracts allow investigators to publish study results per the protocol and publication plan. Medtronic reviews publications to determine if confidential information ("CI") is included. Any such CI is deleted before publication. Medtronic may not censor/interfere with the publication. Investigators may publish single-site publications after a decision by Medtronic that no multi-site study publication will be done or 12 months after the study is closed, whichever is earlier.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated early after 400 of an estimated 1300 subjects required were randomized. The study was terminated due to a pressure lead integrity issue based on analysis of pressure leads from other clinical trials.'}}, 'adverseEventsModule': {'timeFrame': 'Time from enrollment through study closure', 'description': 'The study collected all serious adverse events, all cardiovascular related adverse events, all adverse events related to the implanted system, and all adverse events related to the implant or system-modification procedure.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Arm', 'description': 'Physicians have access to device-based hemodynamic monitor information to guide patient management', 'otherNumAtRisk': 202, 'otherNumAffected': 24, 'seriousNumAtRisk': 202, 'seriousNumAffected': 123}, {'id': 'EG001', 'title': 'Control Arm', 'description': 'Physicians do not have access to device-based hemodynamic monitor information to guide patient management', 'otherNumAtRisk': 198, 'otherNumAffected': 25, 'seriousNumAtRisk': 198, 'seriousNumAffected': 136}, {'id': 'EG002', 'title': 'Enrolled, Not Randomized', 'description': '42 subjects were enrolled but exited the study prior to randomization', 'otherNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'CARDIAC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 45, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 31, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'FEBRILE NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'IDIOPATHIC THROMBOCYTOPENIC PURPURA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'LEUKOCYTOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ACUTE MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ANGINA PECTORIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 24, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ANGINA UNSTABLE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ATRIAL FLUTTER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ATRIOVENTRICULAR BLOCK COMPLETE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'BRADYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'CARDIAC ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'CARDIAC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 138, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 166, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'CARDIO-RESPIRATORY ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'CARDIOMYOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'CORONARY ARTERY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'CORONARY ARTERY STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ELECTROMECHANICAL DISSOCIATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'LOW CARDIAC OUTPUT SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'MITRAL VALVE INCOMPETENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'PERICARDITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'SICK SINUS SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'SINUS ARRHYTHMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'SINUS BRADYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'TRICUSPID VALVE INCOMPETENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'VENTRICULAR ARRHYTHMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'VENTRICULAR FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'VENTRICULAR TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'HYPOTHYROIDISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': "PITUITARY-DEPENDENT CUSHING'S SYNDROME", 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ABDOMINAL ADHESIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ABDOMINAL PAIN', 'stats': 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'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'DIVERTICULAR PERFORATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'GASTROINTESTINAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'GINGIVAL BLEEDING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'HAEMORRHOIDAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ILEUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'IMPAIRED GASTRIC EMPTYING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'HEART TRANSPLANT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ILEOSTOMY CLOSURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'KNEE ARTHROPLASTY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'MITRAL VALVE REPLACEMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'RADIOACTIVE IODINE THERAPY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'THYROIDECTOMY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'VERTEBROPLASTY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ARTERIAL STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'FEMORAL ARTERIAL STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'PERIPHERAL VASCULAR DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'THROMBOPHLEBITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'VENOUS OCCLUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Subjects With an Attempted Implant of the Chronicle ICD System Free From System-related Chronicle ICD Complications at 6-months Post-implant.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronicle ICD Implanted Subjects', 'description': 'Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000', 'lowerLimit': '87.7', 'upperLimit': '93.4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': '6-month survival rate', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '90.5', 'ciLowerLimit': '87.7', 'pValueComment': 'The survival estimate at 6-months post-implant was compared to 80%. The comparison was made using the cumulative hazard \\[e.g. log survival estimate\\] for the variance.', 'groupDescription': 'Null hypothesis: Freedom from Chronicle system-related complications at 6-months post-implant is less than or equal to 80%.\n\nAlternative hypothesis: Freedom from Chronicle system-related complications at 6-months is greater than 80%.', 'statisticalMethod': 'Survival estimate at 6-months', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The survival estimate at 6-months post-implant was compared to 80%.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Within 6 months post-implant', 'description': 'A Chronicle ICD system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death or serious injury of subject, (3) results in the explant of any Chronicle ICD component,and/or (4) causes permanent loss of significant function of the implanted system.', 'unitOfMeasure': 'Percentage of Chronicle ICD Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All 406 subjects with an attempted implant of the Chronicle ICD system.'}, {'type': 'PRIMARY', 'title': 'Percent of Subjects With an Attempted Chronicle IHM Implant Free From Chronicle IHM System-related Complications at 6-months Post-implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronicle IHM Implanted Subjects', 'description': 'Analysis cohort includes the one subject with a Chronicle IHM implant attempt'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months post implant', 'description': 'A Chronicle IHM system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death or serious injury of subject, (3) results in the explant of any Chronicle IHM component,and/or (4) causes permanent loss of significant function of the implanted system.', 'unitOfMeasure': 'Percent of Chronicle IHM subjects', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with an attempted implant of the Chronicle IHM system were included in this analysis. At the time the study stopped, there was only one subject with an attempted Chronicle IHM implant. Thus this objective was not analyzed.'}, {'type': 'PRIMARY', 'title': 'Relative Risk Reduction of All Heart Failure Related Events in the Treatment Group Compared to the Control Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Physicians have access to device-based hemodynamic monitor information to guide patient management'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Physicians do not have access to device-based hemodynamic monitor information to guide patient management'}], 'classes': [{'categories': [{'measurements': [{'value': '0.48', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '0.58'}, {'value': '0.49', 'groupId': 'OG001', 'lowerLimit': '0.39', 'upperLimit': '0.59'}]}]}], 'analyses': [{'pValue': '0.978', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.61', 'pValueComment': 'The P-value is from the Andersen-Gill model, an extension of the Cox proportional hazards model for multiple events.', 'estimateComment': 'Hazard Ratio is for the Treatment Arm relative to the Control Arm.', 'groupDescription': 'The study was originally powered at 80% to detect a 25% risk reduction between the treatment arm and control arm with a type I error rate of 0.05. Under these assumptions 648 HF-related events from approximately 1300 subjects were required. The study stopped after 400 were randomized.\n\nNull Hypothesis: The HF-related event rate is the same between the treatment arm and control arm.\n\nAlternative Hypothesis: The HF-related event rate between the treatment arm and control arm is different.', 'statisticalMethod': 'Andersen-Gill', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 months post-implant', 'description': 'The rate of HF-related events (hospitalizations \\>24h, hospitalizations \\<24h with IV therapy, ED visits with IV therapy, and urgent clinic visits with IV therapy) during the 12-month randomized follow-up period was compared between the Chronicle and Control groups.', 'unitOfMeasure': 'Heart failure related events per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects'}, {'type': 'SECONDARY', 'title': 'Cumulative Days in the Hospital for Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Physicians have access to device-based hemodynamic monitor information to guide patient management'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '22'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '43'}]}]}], 'analyses': [{'pValue': '0.574', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null Hypothesis: mu(Treatment) = mu(Control) Alternative Hypothesis: mu(Treatment) ne mu(Control)\n\nwhere mu is the percentage of hospitalized days for heart failure.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '12 months post-implant', 'description': 'The endpoint for this objective was defined as the cumulative days in hospital for heart failure (HF) expressed as a percentage of hospital free follow-up days during the 12-month randomized period. The relatedness of the events was based on the primary reason for which the subject was originally admitted to the hospital or seen in the emergency department or at an urgent visit, not on the development of new events that occur during hospitalization.', 'unitOfMeasure': 'Percent days in hospital', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All follow-up from all randomized subjects were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Relative Risk Reduction of Cardiovascular Related Events in the Treatment Group Compared to the Control Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Physicians have access to device-based hemodynamic monitor information to guide patient management'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management'}], 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'groupId': 'OG000', 'lowerLimit': '0.64', 'upperLimit': '0.89'}, {'value': '0.86', 'groupId': 'OG001', 'lowerLimit': '0.71', 'upperLimit': '0.98'}]}]}], 'analyses': [{'pValue': '0.527', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.28', 'pValueComment': 'The P-value is from the Andersen-Gill model, an extension of the Cox proportional hazards model for multiple events.', 'estimateComment': 'Hazard Ratio is for the Treatment Arm relative to the Control Arm.', 'groupDescription': 'Null Hypothesis: The CV-related event rate is the same between the treatment arm and control arm.\n\nAlternative Hypothesis: The CV-related event rate between the treatment arm and control arm is different.', 'statisticalMethod': 'Andersen-Gill Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 months post-implant', 'description': 'The rate of CV-related events (hospitalizations \\>24h, hospitalizations \\<24h with IV therapy, ED visits with IV therapy, and urgent clinic visits with IV therapy) during the 12-month randomized follow-up period was compared between the Chronicle and Control groups.', 'unitOfMeasure': 'Cardiovascular related events per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized follow-up for all randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Freedom From All Cause Death or Heart Failure Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Physicians have access to device-based hemodynamic monitor information to guide patient management'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '0.73', 'upperLimit': '0.85'}, {'value': '47', 'groupId': 'OG001', 'lowerLimit': '0.70', 'upperLimit': '0.82'}]}]}], 'analyses': [{'pValue': '0.505', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.32', 'estimateComment': 'Hazard Ratio is for the Treatment Arm relative to the Control Arm', 'groupDescription': 'Null Hypothesis: Freedom from death or HF-related hospitalization is the same between the treatment arm and the control arm.\n\nAlternative Hypothesis: Freedom from death or HF-related hospitalization is different between the treatment arm and the control arm.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The treatment and control hazard ratio and 95% confidence interval was estimated using a univariate cox Regression Model.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months post-implant', 'description': 'Death from any cause or heart failure related hospitalization greater than 24 hours during the 12-month randomized period', 'unitOfMeasure': 'Number of subjects meeting endpoint', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects'}, {'type': 'SECONDARY', 'title': 'Relative Risk of All-cause Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Physicians have access to device-based hemodynamic monitor information to guide patient management'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management'}], 'classes': [{'categories': [{'measurements': [{'value': '1.18', 'groupId': 'OG000', 'lowerLimit': '1.03', 'upperLimit': '1.34'}, {'value': '1.55', 'groupId': 'OG001', 'lowerLimit': '1.36', 'upperLimit': '1.72'}]}]}], 'analyses': [{'pValue': '0.088', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.04', 'estimateComment': 'Hazard Ratio is for the Treatment Arm relative to the Control Arm.', 'groupDescription': 'Null Hypothesis: The all cause event rate is the same between the treatment arm and control arm.\n\nAlternative Hypothesis: The all cause event rate between the treatment arm and control arm is different.', 'statisticalMethod': 'Andersen-Gill Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The P-value is from the Andersen-Gill model, an extension of the Cox proportional hazards model for multiple events.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 months post-implant', 'description': 'All-cause events were defined as hospitalizations, hospitalizations \\<24 hours necessitating intravenous therapy, emergency department visits necessitating intravenous therapy or urgent visits necessitating intravenous therapy.', 'unitOfMeasure': 'All cause event rate per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized follow-up from all randomized subjects'}, {'type': 'SECONDARY', 'title': 'Percentage of Randomized Subjects at Each Level of the Composite Response Endpoint Between the Treatment Arm and the Control Arm.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Physicians have access to device-based hemodynamic monitor information to guide patient management'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management'}], 'classes': [{'title': 'Percent Subjects Improved', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Percent Subjects Unchanged', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Percent Subjects Worsened', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.758', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.54', 'pValueComment': 'P-value is from a proportional odds model comparing the distribution of composite endpoint response between the treatment arm and control arm.', 'estimateComment': 'Odds ratio represents the odds of improved score in the treatment group relative to the control group.', 'groupDescription': 'Null Hypothesis: Distribution of composite response endpoint is the same between the treatment arm and the control arm.\n\nAlternative Hypothesis: Distribution of composite response endpoint is different between the treatment arm and the control arm.', 'statisticalMethod': 'Proportional odds model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months post implant', 'description': 'The definitions of worsened, improved, and unchanged are as follows:\n\nWorsened: Subject dies, is hospitalized for worsening heart failure, permanently discontinues blinded randomized assignment and has worsening heart failure at time of study discontinuation, demonstrates worsening NYHA Class at LOCF, or moderate-marked worsening of global assessment score at LOCF.\n\nImproved: Subject has not worsened, and demonstrates improvement in NYHA class and/or moderate-marked improvement in subject global assessment score.\n\nUnchanged: Subject is neither worsened nor improved.', 'unitOfMeasure': 'Percent of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized follow-up from all randomized subjects were included.'}, {'type': 'SECONDARY', 'title': 'Characterize Health Resource Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Physicians have access to device-based hemodynamic monitor information to guide patient management'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Physicians do not have access to device-based hemodynamic monitor information to guide patient management'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5.3'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '35.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months post implant', 'description': 'Percentage of randomized days spent in the intensive care unit for heart failure. Reason for hospitalization was determined by the adverse event adjudication committee.', 'unitOfMeasure': 'percentage of randomized days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Characterize Randomized Days Alive Out of Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Physicians have access to device-based hemodynamic monitor information to guide patient management'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Physicians do not have access to device-based hemodynamic monitor information to guide patient management'}], 'classes': [{'categories': [{'measurements': [{'value': '340', 'spread': '65', 'groupId': 'OG000'}, {'value': '341', 'spread': '63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months post implant', 'description': 'Randomized days alive outside of the hospital was computed for each subject as the total number of randomized days minus the number of randomized days spent in the hospital for any cause.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Characterize Subject Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Physicians have access to device-based hemodynamic monitor information to guide patient management'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Physicians do not have access to device-based hemodynamic monitor information to guide patient management'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.599', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.29', 'ciUpperLimit': '2.06', 'estimateComment': 'Hazard ratio estimates the hazard of death in the treatment group relative to the control group.', 'groupDescription': 'Null hypothesis: Survival during the 12-month randomized follow-up period is the same between the treatment and control groups.\n\nAlternative hypothesis: Survival during the 12-month randomized period is different between the treatment and control groups.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The treatment to control hazard ratio and 95% confidence interval was estimated using a univariate Cox Regression Model', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months post implant', 'description': 'Death from any cause during the 12-month randomization period', 'unitOfMeasure': 'number of deaths', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Characterize Medication Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Physicians have access to device-based hemodynamic monitor information to guide patient management'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Physicians do not have access to device-based hemodynamic monitor information to guide patient management'}], 'classes': [{'categories': [{'measurements': [{'value': '1.77', 'groupId': 'OG000'}, {'value': '1.49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.145', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The null hypothesis is that the rate of cardiovascular medication changes is the same between the Treatment Arm and Control Arm.', 'statisticalMethod': 'Negative-Binomial Regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months post implant', 'description': 'The rate of change of cardiovascular medications in changes per subject month were computed and compared between treatment groups.', 'unitOfMeasure': 'Medication changes per subject month', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Characterize Intracardiac Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Physicians have access to device-based hemodynamic monitor information to guide patient management'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Physicians do not have access to device-based hemodynamic monitor information to guide patient management'}], 'classes': [{'categories': [{'measurements': [{'value': '22.0', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '23.3', 'spread': '6.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.033', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: Average daily median ePAD is the same between the Treatment and Control arms.\n\nAlternative hypothesis: Average daily median ePAD is the different between the Treatment and Control arms.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 months post implant', 'description': 'The average daily median estimated pulmonary arterial diastolic pressure (ePAD) was computed for each subject with at least 90 days of ePAD data available and compared between the Treatment and Control arms.', 'unitOfMeasure': 'ePAD mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'At least 90 days of ePAD data were required for each subject during the 12-month randomized period to be included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Characterize Intracardiac Pressure Changes in Response to Subject Clinical Signs and Symptoms of Heart Failure Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Heart Failure Event Free Control Subjects', 'description': 'Subjects randomized to the Control Arm that did not have a heart failure related event during the 12-month randomized period'}, {'id': 'OG001', 'title': 'Heart Failure Event Control Subjects', 'description': 'Subjects randomized to the Control Arm that had a heart failure event during the 12-month randomized period'}], 'classes': [{'categories': [{'measurements': [{'value': '26.3', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '22.5', 'spread': '6.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null Hypothesis: The average daily median ePAD is not different among Control Arm subjects that have and that do not have a heart failure related event during the 12-month follow-up period.\n\nAlternative Hypothesis: The average daily median ePAD is different among Control Arm subjects that have and that do not have a heart failure related event during the 12-month follow-up period.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 months post implant', 'description': 'The average daily median estimated pulmonary arterial diastolic pressure (ePAD) was computed for each subject with at least 90 days of ePAD data available and compared between the Control Arm subjects with and without a heart failure related event during the 12-month randomized period.', 'unitOfMeasure': 'ePAD mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Control Arm subjects with at least 90 days of pressure data available during the 12-month randomized follow-up period.'}, {'type': 'SECONDARY', 'title': 'Characterize NYHA Functional Class', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Physicians have access to device-based hemodynamic monitor information to guide patient management'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Physicians do not have access to device-based hemodynamic monitor information to guide patient management'}], 'classes': [{'title': 'Percent Subjects NYHA Class II Baseline', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '51'}, {'value': '48', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '48'}]}]}, {'title': 'Percent Subjects NYHA Class III Baseline', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Percent Subjects NYHA Class I Month 12', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Percent Subjects NYHA Class II Month 12', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Percent Subjects NYHA Class III Month 12', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Percent Subjects NYHA Class IV Month 12', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Percent Subjects Improved NYHA Class', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Percent Subjects No Change in NYHA Class', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Percent Subjects Worsened NYHA Class', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.292', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.96', 'estimateComment': 'Direction for odds ratio is the odds of improvement in the Treatment arm versus the odds of improvement in the Control arm.', 'groupDescription': 'Null Hypothesis: There is no difference in the change in NYHA functional class between the Treatment and Control Arms.\n\nAlternative Hypothesis: There is a difference in the change in NYHA functional class between the Treatment and Control Arms.', 'statisticalMethod': 'Proportional odds regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'baseline to 12 months post implant', 'description': 'The outcome is the change in NYHA functional class between the baseline visit and the 12-month follow-up visit. At baseline subjects were required to be NYHA functional class II or III. The outcome will show the percentage of subjects that were functional class II and III at baseline and functional class I, II, III, or IV at the 12-month visit. The percent improvement from baseline is calculated as the percentage of subjects with a lower NYHA functional class at the 12-month visit compared to their NHYA functional class at baseline.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects were required to have an NYHA functional class assessment at the baseline and 12-month follow-up visit to be included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Characterize Distance Walked in Six Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Physicians have access to device-based hemodynamic monitor information to guide patient management'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Physicians do not have access to device-based hemodynamic monitor information to guide patient management'}], 'classes': [{'title': 'Baseline visit', 'categories': [{'measurements': [{'value': '313.2', 'spread': '124.8', 'groupId': 'OG000'}, {'value': '308.7', 'spread': '133.5', 'groupId': 'OG001'}]}]}, {'title': '12-month visit', 'categories': [{'measurements': [{'value': '354.5', 'spread': '178.8', 'groupId': 'OG000'}, {'value': '347.2', 'spread': '160.4', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 12-months', 'categories': [{'measurements': [{'value': '41.3', 'spread': '160.5', 'groupId': 'OG000'}, {'value': '38.5', 'spread': '154.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.996', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null Hypothesis: The change in 6-minute hall walk distance is not different between the Treatment and Control Arms.\n\nAlternative Hypothesis: The change in 6-minute hall walk distance is different between the Treatment and Control Arms.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 12 months post implant', 'description': 'The outcome is the change in distance walked in 6-minutes in meters between the baseline visit and the 12-month follow-up visit. The change in distance walked was calculated within each subject as the distance walked in 6-minutes at the 12-month visit minus the distance walked in 6-minutes at the baseline visit. Positive values indicate an increase in the distance walked in 6-minutes from baseline.', 'unitOfMeasure': 'distance walked in 6-minutes (meters)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects were required to complete the 6-minute hall walk test at both the baseline and 12-month visit to be included in the analysis of this objective.'}, {'type': 'SECONDARY', 'title': 'Characterize Renal Function at the Baseline and 12-month Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Physicians have access to device-based hemodynamic monitor information to guide patient management'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Physicians do not have access to device-based hemodynamic monitor information to guide patient management'}], 'classes': [{'title': 'Baseline eGFR', 'categories': [{'measurements': [{'value': '72.4', 'spread': '26.2', 'groupId': 'OG000'}, {'value': '69.8', 'spread': '20.4', 'groupId': 'OG001'}]}]}, {'title': '12-month eGFR', 'categories': [{'measurements': [{'value': '68.6', 'spread': '27.7', 'groupId': 'OG000'}, {'value': '69.2', 'spread': '25.6', 'groupId': 'OG001'}]}]}, {'title': 'Change in eGFR from baseline to 12-months', 'categories': [{'measurements': [{'value': '-3.8', 'spread': '22.0', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '19.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.154', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null Hypothesis: The change from baseline to the 12-month follow-up visit in eGFR values is the same between the Treatment arm and Control arm.\n\nAlternative Hypothesis: The change from baseline to the 12-month follow-up visit in eGFR values is different between the Treatment arm and Control arm.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 12 months post implant', 'description': 'Change in estimated glomerular filtration rate (eGFR) from baseline to the 12-month follow-up visit. eGFR was estimated using the MDRD forumula from the National Kidney Foundation (American Journal of Kidney Diseases 39: S1-299). Change in eGFR was computed as the 12-month eGFR value minus the baseline eGFR value. Positive values indicate an increase in eGFR from baseline and negative values indicate a decrease in eGFR from baseline.', 'unitOfMeasure': 'mL/min/1.73 m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects were required to have creatinine values available at the baseline and 12-month visit to be included in the analysis of this objective.'}, {'type': 'SECONDARY', 'title': 'Characterize Intracardiac Pressure Monitoring Following Defibrillation Testing (Chronicle ICD Subjects Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronicle ICD Implanted Subjects', 'description': 'Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system'}], 'classes': [{'categories': [{'measurements': [{'value': '99.7', 'groupId': 'OG000', 'lowerLimit': '98.5', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'implant', 'description': 'Intracardiac pressure monitoring was deemed successful following defibrillation testing if physiological pressure waveforms were present following defibrillation testing.', 'unitOfMeasure': 'Percentage of subjects with waveforms', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 406 subjects with an attempted implant of the Chronicle ICD system, 366 completed defibrillation testing as part of their ICD implant procedure.'}, {'type': 'SECONDARY', 'title': 'Characterize Defibrillation Threshold Testing Efficacy (Chronicle ICD Subjects Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronicle ICD Implanted Subjects', 'description': 'Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system'}], 'classes': [{'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '99.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Implant', 'description': 'The outcome measure is the percentage of subjects implanted with the Chronicle ICD who completed defibrillation testing and had a 10 Joule safety margin', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 406 subjects with an attempted implant of the Chronicle ICD system, 366 completed defibrillation testing.'}, {'type': 'SECONDARY', 'title': 'Characterize Quality of Life at Baseline and 12-month Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Physicians have access to device-based hemodynamic monitor information to guide patient management'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Physicians do not have access to device-based hemodynamic monitor information to guide patient management'}], 'classes': [{'title': 'Baseline MNWHF score', 'categories': [{'measurements': [{'value': '49.7', 'spread': '26.4', 'groupId': 'OG000'}, {'value': '52.7', 'spread': '28.0', 'groupId': 'OG001'}]}]}, {'title': '12-month MNWHF score', 'categories': [{'measurements': [{'value': '34.0', 'spread': '25.6', 'groupId': 'OG000'}, {'value': '37.2', 'spread': '25.9', 'groupId': 'OG001'}]}]}, {'title': 'Change in MNWHF score from baseline', 'categories': [{'measurements': [{'value': '-15.7', 'spread': '27.3', 'groupId': 'OG000'}, {'value': '-15.6', 'spread': '23.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.583', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null Hypothesis: There is no difference in the change in MNLWHF score from baseline to 12-months between the Treatment Arm and Control Arm.\n\nAlternative Hypothesis: There is a difference in the change in MNLWHF score from baseline to 12-months between the Treatment Arm and Control Arm.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Response was change in MNLWHF score from baseline. Model adjusted for baseline MNLWHF score. Negative changes mean an improvement in MNLWHF score.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 12 months post implant', 'description': 'The outcome is the change in the Minnesota Living with Heart Failure® (MNLWHF) questionnaire response from baseline to the 12-month follow-up visit. The MNLWHF questionnaire is a 21 question questionnaire scored from zero (no impact of heart failure) to 5 (severe impact of heart failure). The composite MNLWHF score ranges from 0 (no impact of heart failure) to 105 (severe impact of heart failure). Change in MNLWHF score was computed as the 12-month minus the baseline score.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects were required to respond to the baseline and 12-month follow-up visit to be included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Characterize Arrhythmic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Physicians have access to device-based hemodynamic monitor information to guide patient management'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Physicians do not have access to device-based hemodynamic monitor information to guide patient management'}], 'classes': [{'categories': [{'measurements': [{'value': '0.54', 'groupId': 'OG000', 'lowerLimit': '0.43', 'upperLimit': '0.64'}, {'value': '0.38', 'groupId': 'OG001', 'lowerLimit': '0.29', 'upperLimit': '0.47'}]}]}], 'analyses': [{'pValue': '0.368', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.48', 'ciLowerLimit': '0.63', 'ciUpperLimit': '3.5', 'pValueComment': 'The P-value is from the Andersen-Gill model which adjusts for multiple VT/VF episodes per subject.', 'groupDescription': 'Null Hypothesis: Rate of VT/VF episodes during the 12-month randomized period is the same between the Treatment Arm and the Control Arm.\n\nAlternative Hypothesis: Rate of VT/VF episodes during the 12-month randomized period is different between the Treatment Arm and the Control Arm.', 'statisticalMethod': 'Andersen-Gill Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Andersen-Gill model included a term for Treatment Arm. This model adjusts for multiple events per subject.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months post implant', 'description': 'The rate of spontaneous VT (ventricular tachycardia)/VF (ventricular fibrillation) episodes during the 12-month follow-up period in episodes per subject month was compared between the Treatment Arm and the Control Arm', 'unitOfMeasure': 'VT/VF episodes per subject month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All 399 subjects successfully implanted with the Chronicle ICD were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Arm', 'description': 'Physicians have access to device-based hemodynamic monitor information to guide patient management'}, {'id': 'FG001', 'title': 'Control Arm', 'description': 'Physicians do not have access to device-based hemodynamic monitor information to guide patient management'}], 'periods': [{'title': 'Randomized Study Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '202'}, {'groupId': 'FG001', 'numSubjects': '198'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}, {'groupId': 'FG001', 'numSubjects': '176'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}, {'title': 'Long-term Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Number entering post 12-month non-randomized long-term follow-up period', 'groupId': 'FG000', 'numSubjects': '180'}, {'comment': 'Number entering post 12-month non-randomized long-term follow-up period', 'groupId': 'FG001', 'numSubjects': '176'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'All subjects were exited at the time of study closure', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'All subjects were exited at the time of study closure', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}, {'groupId': 'FG001', 'numSubjects': '176'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '127'}, {'groupId': 'FG001', 'numSubjects': '122'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Study Closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '34'}]}]}], 'recruitmentDetails': 'Recruitment began on April 28, 2006 and ended on January 14, 2011. All subjects were exited from the study on January 14, 2011. Fifty-three US clinical centers participated in the REDUCEhf study.', 'preAssignmentDetails': 'Enrolled subjects were required to have a successful implant of the Chronicle® device prior to randomization. 407 subjects had an attempted implant of the Chronicle® ICD (Implantable Cardioverter Defibrillator) (406) or Chronicle IHM (Implantable Hemodynamic Monitor) (1 subject). Of these 407 subjects, 400 were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Arm', 'description': 'Physicians have access to device-based hemodynamic monitor information to guide patient management'}, {'id': 'BG001', 'title': 'Control Arm', 'description': 'Physicians do not have access to device-based hemodynamic monitor information to guide patient management'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'spread': '14.7', 'groupId': 'BG000'}, {'value': '54.7', 'spread': '14.8', 'groupId': 'BG001'}, {'value': '54.7', 'spread': '14.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'NYHA (New York Heart Association) Classification', 'classes': [{'title': 'NYHA Class II', 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}]}]}, {'title': 'NYHA Class III', 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Class II and Class III NYHA classification\n\nClass II Subjects with cardiac disease resulting in slight limitation of physical activity.They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina.\n\nClass III Subjects with cardiac disease resulting in marked limitation of physical activity.They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or angina.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 442}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-07', 'studyFirstSubmitDate': '2006-07-19', 'resultsFirstSubmitDate': '2012-01-12', 'studyFirstSubmitQcDate': '2006-07-19', 'lastUpdatePostDateStruct': {'date': '2012-08-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-07', 'studyFirstPostDateStruct': {'date': '2006-07-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Subjects With an Attempted Implant of the Chronicle ICD System Free From System-related Chronicle ICD Complications at 6-months Post-implant.', 'timeFrame': 'Within 6 months post-implant', 'description': 'A Chronicle ICD system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death or serious injury of subject, (3) results in the explant of any Chronicle ICD component,and/or (4) causes permanent loss of significant function of the implanted system.'}, {'measure': 'Percent of Subjects With an Attempted Chronicle IHM Implant Free From Chronicle IHM System-related Complications at 6-months Post-implant', 'timeFrame': '6 months post implant', 'description': 'A Chronicle IHM system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death or serious injury of subject, (3) results in the explant of any Chronicle IHM component,and/or (4) causes permanent loss of significant function of the implanted system.'}, {'measure': 'Relative Risk Reduction of All Heart Failure Related Events in the Treatment Group Compared to the Control Group', 'timeFrame': '12 months post-implant', 'description': 'The rate of HF-related events (hospitalizations \\>24h, hospitalizations \\<24h with IV therapy, ED visits with IV therapy, and urgent clinic visits with IV therapy) during the 12-month randomized follow-up period was compared between the Chronicle and Control groups.'}], 'secondaryOutcomes': [{'measure': 'Cumulative Days in the Hospital for Heart Failure', 'timeFrame': '12 months post-implant', 'description': 'The endpoint for this objective was defined as the cumulative days in hospital for heart failure (HF) expressed as a percentage of hospital free follow-up days during the 12-month randomized period. The relatedness of the events was based on the primary reason for which the subject was originally admitted to the hospital or seen in the emergency department or at an urgent visit, not on the development of new events that occur during hospitalization.'}, {'measure': 'Relative Risk Reduction of Cardiovascular Related Events in the Treatment Group Compared to the Control Group', 'timeFrame': '12 months post-implant', 'description': 'The rate of CV-related events (hospitalizations \\>24h, hospitalizations \\<24h with IV therapy, ED visits with IV therapy, and urgent clinic visits with IV therapy) during the 12-month randomized follow-up period was compared between the Chronicle and Control groups.'}, {'measure': 'Freedom From All Cause Death or Heart Failure Hospitalization', 'timeFrame': '12 months post-implant', 'description': 'Death from any cause or heart failure related hospitalization greater than 24 hours during the 12-month randomized period'}, {'measure': 'Relative Risk of All-cause Events', 'timeFrame': '12 months post-implant', 'description': 'All-cause events were defined as hospitalizations, hospitalizations \\<24 hours necessitating intravenous therapy, emergency department visits necessitating intravenous therapy or urgent visits necessitating intravenous therapy.'}, {'measure': 'Percentage of Randomized Subjects at Each Level of the Composite Response Endpoint Between the Treatment Arm and the Control Arm.', 'timeFrame': '12 months post implant', 'description': 'The definitions of worsened, improved, and unchanged are as follows:\n\nWorsened: Subject dies, is hospitalized for worsening heart failure, permanently discontinues blinded randomized assignment and has worsening heart failure at time of study discontinuation, demonstrates worsening NYHA Class at LOCF, or moderate-marked worsening of global assessment score at LOCF.\n\nImproved: Subject has not worsened, and demonstrates improvement in NYHA class and/or moderate-marked improvement in subject global assessment score.\n\nUnchanged: Subject is neither worsened nor improved.'}, {'measure': 'Characterize Health Resource Utilization', 'timeFrame': '12 months post implant', 'description': 'Percentage of randomized days spent in the intensive care unit for heart failure. Reason for hospitalization was determined by the adverse event adjudication committee.'}, {'measure': 'Characterize Randomized Days Alive Out of Hospital', 'timeFrame': '12 months post implant', 'description': 'Randomized days alive outside of the hospital was computed for each subject as the total number of randomized days minus the number of randomized days spent in the hospital for any cause.'}, {'measure': 'Characterize Subject Survival', 'timeFrame': '12 months post implant', 'description': 'Death from any cause during the 12-month randomization period'}, {'measure': 'Characterize Medication Usage', 'timeFrame': '12 months post implant', 'description': 'The rate of change of cardiovascular medications in changes per subject month were computed and compared between treatment groups.'}, {'measure': 'Characterize Intracardiac Pressure', 'timeFrame': '12 months post implant', 'description': 'The average daily median estimated pulmonary arterial diastolic pressure (ePAD) was computed for each subject with at least 90 days of ePAD data available and compared between the Treatment and Control arms.'}, {'measure': 'Characterize Intracardiac Pressure Changes in Response to Subject Clinical Signs and Symptoms of Heart Failure Events', 'timeFrame': '12 months post implant', 'description': 'The average daily median estimated pulmonary arterial diastolic pressure (ePAD) was computed for each subject with at least 90 days of ePAD data available and compared between the Control Arm subjects with and without a heart failure related event during the 12-month randomized period.'}, {'measure': 'Characterize NYHA Functional Class', 'timeFrame': 'baseline to 12 months post implant', 'description': 'The outcome is the change in NYHA functional class between the baseline visit and the 12-month follow-up visit. At baseline subjects were required to be NYHA functional class II or III. The outcome will show the percentage of subjects that were functional class II and III at baseline and functional class I, II, III, or IV at the 12-month visit. The percent improvement from baseline is calculated as the percentage of subjects with a lower NYHA functional class at the 12-month visit compared to their NHYA functional class at baseline.'}, {'measure': 'Characterize Distance Walked in Six Minutes', 'timeFrame': 'baseline to 12 months post implant', 'description': 'The outcome is the change in distance walked in 6-minutes in meters between the baseline visit and the 12-month follow-up visit. The change in distance walked was calculated within each subject as the distance walked in 6-minutes at the 12-month visit minus the distance walked in 6-minutes at the baseline visit. Positive values indicate an increase in the distance walked in 6-minutes from baseline.'}, {'measure': 'Characterize Renal Function at the Baseline and 12-month Visit', 'timeFrame': 'baseline to 12 months post implant', 'description': 'Change in estimated glomerular filtration rate (eGFR) from baseline to the 12-month follow-up visit. eGFR was estimated using the MDRD forumula from the National Kidney Foundation (American Journal of Kidney Diseases 39: S1-299). Change in eGFR was computed as the 12-month eGFR value minus the baseline eGFR value. Positive values indicate an increase in eGFR from baseline and negative values indicate a decrease in eGFR from baseline.'}, {'measure': 'Characterize Intracardiac Pressure Monitoring Following Defibrillation Testing (Chronicle ICD Subjects Only)', 'timeFrame': 'implant', 'description': 'Intracardiac pressure monitoring was deemed successful following defibrillation testing if physiological pressure waveforms were present following defibrillation testing.'}, {'measure': 'Characterize Defibrillation Threshold Testing Efficacy (Chronicle ICD Subjects Only)', 'timeFrame': 'Implant', 'description': 'The outcome measure is the percentage of subjects implanted with the Chronicle ICD who completed defibrillation testing and had a 10 Joule safety margin'}, {'measure': 'Characterize Quality of Life at Baseline and 12-month Visit', 'timeFrame': 'baseline to 12 months post implant', 'description': 'The outcome is the change in the Minnesota Living with Heart Failure® (MNLWHF) questionnaire response from baseline to the 12-month follow-up visit. The MNLWHF questionnaire is a 21 question questionnaire scored from zero (no impact of heart failure) to 5 (severe impact of heart failure). The composite MNLWHF score ranges from 0 (no impact of heart failure) to 105 (severe impact of heart failure). Change in MNLWHF score was computed as the 12-month minus the baseline score.'}, {'measure': 'Characterize Arrhythmic Events', 'timeFrame': '12 months post implant', 'description': 'The rate of spontaneous VT (ventricular tachycardia)/VF (ventricular fibrillation) episodes during the 12-month follow-up period in episodes per subject month was compared between the Treatment Arm and the Control Arm'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Implantable cardioverter defibrillator', 'Intracardiac pressures'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '23515265', 'type': 'DERIVED', 'citation': 'Reiter MJ, Stromberg KD, Whitman TA, Adamson PB, Benditt DG, Gold MR. Influence of intracardiac pressure on spontaneous ventricular arrhythmias in patients with systolic heart failure: insights from the REDUCEhf trial. Circ Arrhythm Electrophysiol. 2013 Apr;6(2):272-8. doi: 10.1161/CIRCEP.113.000223. Epub 2013 Mar 20.'}, {'pmid': '18000962', 'type': 'DERIVED', 'citation': 'Adamson PB, Conti JB, Smith AL, Abraham WT, Aaron MF, Aranda JM Jr, Baker J, Bourge RC, Warner-Stevenson L, Sparks B. Reducing events in patients with chronic heart failure (REDUCEhf ) study design: continuous hemodynamic monitoring with an implantable defibrillator. Clin Cardiol. 2007 Nov;30(11):567-75. doi: 10.1002/clc.20250.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical research study is to evaluate the safety and effectiveness of the investigational implantable hemodynamic monitor (IHM), and of the IHM in combination with an implantable cardioverter defibrillator (ICD). The investigational IHM has the ability to record and report the force with which the heart pumps blood (heart pressures). When combined with the ICD, the device has the additional ability to send a strong electrical impulse, or shock, to the heart when it detects dangerously fast heartbeats to return it to a normal rhythm. The IHM and IHM/ICD are implanted surgically just under the skin in the upper chest area. This study will also determine how doctors use the information related to heart pressures in the management of heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects with heart failure that only sometimes interferes with daily activities (New York Heart Association \\[NYHA\\] Class II (1)) or subjects with heart failure which severely limits daily activities (NYHA Class III (2)) at baseline\n* Subject has appropriate medical therapy for heart failure (such as diuretic, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and beta blocker) for at least three months prior to the baseline evaluation.\n* Subject has been on stable medications maximized to the subject's tolerance of ACE or ARB and beta blockers as determined by the study investigator for at least 30 days prior to baseline evaluation. (Stable is defined as no more than a 100% increase or a 50% decrease in dose.) If a subject is intolerant of ACE, ARB or beta blockers documented evidence must be available.\n* Subject has had at least one heart failure-related hospitalization or at least one heart failure-related emergency department or urgent care visit necessitating heart failure-related intravenous therapy (e.g. diuretic administration) within 12 months prior to the baseline evaluation\n* To be considered for Chronicle ICD: Subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD).\n\n 1. Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina.\n 2. Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or angina.\n\nExclusion Criteria:\n\n* Subjects with severe heart failure who should always be resting (NYHA Class IV(3)) or Stage D(4) refractory heart failure.\n* Subjects with severe renal dysfunction.\n* Subjects with severe non-cardiac condition limiting 12-month survival.\n* Subjects in concurrent studies that may confound the results.\n\n (3)Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.\n\n (4)Stage D refractory heart failure: Patients who have marked symptoms at rest despite maximal medical therapy (e.g., those who are recurrently hospitalized or cannot be safely discharged from the hospital without specialized interventions)"}, 'identificationModule': {'nctId': 'NCT00354159', 'acronym': 'REDUCEhf', 'briefTitle': 'Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (HF) (REDUCEhf)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic HF (REDUCEhf)', 'orgStudyIdInfo': {'id': '103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm', 'description': 'Physicians have access to device-based hemodynamic monitor information to guide patient management', 'interventionNames': ['Device: Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Arm', 'description': 'Physicians do not have access to device-based hemodynamic monitor information to guide patient management', 'interventionNames': ['Device: Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD)']}], 'interventions': [{'name': 'Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD)', 'type': 'DEVICE', 'otherNames': ['Chronicle® IHM, Chronicle® ICD'], 'description': 'Surgical implantation of hemodynamic device (IHM), or IHM/ICD, and intracardiac leads.', 'armGroupLabels': ['Control Arm', 'Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham (UAB)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Green Hospital', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Long Beach Memorial', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95350', 'city': 'Modesto', 'state': 'California', 'country': 'United States', 'facility': 'Doctors Medical Center Modesto', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University, School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Hospital', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of FL Shands', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Crawford Long/Emory University Hospitals', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60148', 'city': 'Lombard', 'state': 'Illinois', 'country': 'United States', 'facility': 'Midwest Heart Foundation', 'geoPoint': {'lat': 41.88003, 'lon': -88.00784}}, {'zip': '52803', 'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'facility': 'Genesis Hospital Midwest Cardiovascular Research Foundation', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Heart Center', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham & Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic Medical Center', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Memorial Medical Center', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'St Joseph Mercy Hospital', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55433', 'city': 'Coon Rapids', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mercy Hospital Metropolitan Cardiology Consultants', 'geoPoint': {'lat': 45.11997, 'lon': -93.28773}}, {'zip': '38801', 'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'facility': 'North Mississippi Medical Center', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mid America Heart Institute/St. Lukes', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68506', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Bryan LGH Heart Institute', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '07962', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Morristown Memorial Hospital', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mt Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Presbyterian Hospital Mid Carolinas Cardiology', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Forsyth Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73120', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Heart Hospital', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lehigh Valley Heart Specialists', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '17603', 'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lancaster Heart & Stroke Foundation', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Drexel University College of Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny General Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '19096', 'city': 'Wynnewood', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lankenau Hospital', 'geoPoint': {'lat': 40.00289, 'lon': -75.27074}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Spartanburg Regional', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Baptist Hospital', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'St Thomas', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75226', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Research Institute', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Fletcher Allen Health Care', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Health System', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Fairfax Hospital', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Norfolk General Hospital', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Hospital & Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Phillip Adamson, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Oklahoma Heart Hospital'}, {'name': 'Michael Gold, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}