Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-27 @ 6:58 PM
Study NCT ID:
NCT04722250
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-19
First Post:
2021-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rs.smarttrial@medtronic.com', 'phone': '763 514 4000', 'title': 'Myra Fan Director', 'organization': 'Medtronic Cardiovascular'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected starting at the time the Informed Consent was signed through the primary endpoint snapshot. In this table we report all events from date of procedure through 365 days post procedure for each subject.', 'description': 'All serious adverse events S(AEs),non-serious endpoint-related AEs and adverse device effects (ADEs) that occurred during the study need to be reported throughout the trial duration. AEs are reported according to first device attempted at the TAVR procedure (As Treated Set). Subjects attempted with assigned device and subsequently implanted with the other device are also reported. \\*Note there were no non-serious events by MedDRA preferred term, that exceeded the 5% frequency threshold reporting', 'eventGroups': [{'id': 'EG000', 'title': 'Attempted Medtronic Self-Expanding TAV (As Treated Set)', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)\n\n\\*\\*Note: As Treated set (all subjects with attempted TAVR procedure according to first device used)', 'otherNumAtRisk': 355, 'deathsNumAtRisk': 355, 'otherNumAffected': 0, 'seriousNumAtRisk': 355, 'deathsNumAffected': 18, 'seriousNumAffected': 210}, {'id': 'EG001', 'title': 'Attempted Edwards Balloon-Expandable THV (As Treated Set)', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System\n\n\\*\\*Note: As Treated set (all subjects with attempted TAVR procedure according to first device used)', 'otherNumAtRisk': 361, 'deathsNumAtRisk': 361, 'otherNumAffected': 0, 'seriousNumAtRisk': 361, 'deathsNumAffected': 21, 'seriousNumAffected': 207}, {'id': 'EG002', 'title': 'Attempted Both Devices', 'description': 'This arm contains subjects that had a procedural cross-over (i.e., subjects who were first attempted with one device (per randomization assignment) and implanted with the other device at the time of the index TAVR procedure).\n\nThese subjects are analyzed with the other treatment device in the implanted set.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 2, 'seriousNumAffected': 4}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Blood loss anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acquired left ventricle outflow tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 25, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Atrial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 34, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bifascicular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiorenal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Conduction disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Intracardiac thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Microvascular coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nodal arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pericardial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pulseless electrical activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Trifascicular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ventricular hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Keratoplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Peripheral artery bypass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Aortic arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arteriovenous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Femoral artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypertensive urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Iliac artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pelvic venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Subgaleal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Superficial vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vascular occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mortality, Disabling Stroke or Heart Failure Rehospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)'}, {'id': 'OG001', 'title': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000'}, {'value': '10.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.2', 'ciLowerLimit': '-4.9', 'ciUpperLimit': '2.5', 'statisticalMethod': 'z-test on Kaplan-Meier percentages', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The endpoint is designed to test whether the Medtronic SE TAV is non-inferior to Edwards BE TAV in the composite event rate of all-cause mortality, disabling stroke or heart failure rehospitalization at 12 months post-procedure with an absolute non-inferiority margin of 8.0%.'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percentage of participants with all-cause mortality, disabling stroke, or heart failure rehospitalization.', 'unitOfMeasure': 'Percent of Participants (K-M Rate)', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated set (all subjects with attempted TAVR procedure according to first device used)'}, {'type': 'PRIMARY', 'title': 'Bioprosthetic Valve Dysfunction (BVD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '350', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)'}, {'id': 'OG001', 'title': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000'}, {'value': '41.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-32.2', 'ciLowerLimit': '-38.7', 'ciUpperLimit': '-25.6', 'statisticalMethod': 'z-test on Kaplan-Meier percentages', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percentage of participants with BVD (hemodynamic structural valve dysfunction (hemodynamic mean gradient ≥ 20mmHg), non-structural valve dysfunction (severe prosthesis-patient mismatch and/or ≥ moderate total aortic regurgitation), thrombosis, endocarditis, or aortic valve re-intervention) at 12 months.', 'unitOfMeasure': 'Percent of Participants (K-M Rate)', 'reportingStatus': 'POSTED', 'populationDescription': 'Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted). \\*Note that a subject who is first attempted with one device then subsequently implanted with the other device will be analyzed according to the last implanted device.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With BVD in Female Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)'}, {'id': 'OG001', 'title': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000'}, {'value': '41.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'unitOfMeasure': 'percentage of participants (K-M rate)', 'reportingStatus': 'POSTED', 'populationDescription': 'Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted) \\*Note that a subject who is first attempted with one device then subsequently implanted with the other device will be analyzed according to the last implanted device.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Hemodynamic Structural Valve Dysfunction (HSVD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '350', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)'}, {'id': 'OG001', 'title': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '32.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'HSVD is defined as hemodynamic mean gradient ≥ 20mmHg on any echocardiogram after implant procedure.', 'unitOfMeasure': 'percentage of participants (K-M rate)', 'reportingStatus': 'POSTED', 'populationDescription': 'Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted) \\*Note that a subject who is first attempted with one device then subsequently implanted with the other device will be analyzed according to the last implanted device.'}, {'type': 'SECONDARY', 'title': 'Hemodynamic Mean Gradient as Continuous Variable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)'}, {'id': 'OG001', 'title': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '15.7', 'spread': '6.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Mean aortic gradient as measured by echocardiogram at the 12-month visit.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted)'}, {'type': 'SECONDARY', 'title': 'Effective Orifice Area (EOA) as a Continuous Variable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)'}, {'id': 'OG001', 'title': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System'}], 'classes': [{'categories': [{'measurements': [{'value': '1.98', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Effective Orifice Area (EOA) as measured by echocardiogram at the 12-month visit.', 'unitOfMeasure': 'cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted)'}, {'type': 'SECONDARY', 'title': 'Rate of Moderate or Severe Prothesis-patient Mismatch (PPM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)'}, {'id': 'OG001', 'title': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Moderate or severe PPM will be defined as follows:\n\nFor subjects with BMI \\< 30 kg/m2\n\n* Moderate PPM: EOAI = 0.85 - 0.65 cm2/m2\n* Severe PPM: EOAI = ≤ 0.65 cm2/m2\n\nFor subjects with BMI ≥ 30 kg/m2\n\n* Moderate PPM: EOAI = 0.70 - 0.55 cm2/m2\n* Severe PPM: EOAI = ≤ 0.55 cm2/m2', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Device Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)'}, {'id': 'OG001', 'title': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System'}], 'classes': [{'categories': [{'measurements': [{'value': '248', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Device Success is defined as meeting all of the following:\n\nFreedom from mortality AND Correct positioning of a single prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch (PPM) and mean aortic valve gradient \\<20 mmHg or peak velocity \\<3 m/s) AND No moderate or severe prosthetic valve regurgitation)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated set (all subjects with attempted TAVR procedure according to first device used)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of an Early Safety Composite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)'}, {'id': 'OG001', 'title': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000'}, {'value': '7.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Incidence of an early safety composite at 30 days defined as:\n\n* All-cause mortality\n* All stroke (disabling and non-disabling)\n* Life-threatening bleeding\n* Acute kidney injury-Stage 2 or 3 (including renal replacement therapy)\n* Coronary artery obstruction requiring intervention\n* Major vascular complication\n* Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)', 'unitOfMeasure': 'percentage of participants (K-M rate)', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated set (all subjects with attempted TAVR procedure according to first device used)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hospital Readmission Rate for Any Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)'}, {'id': 'OG001', 'title': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000'}, {'value': '11.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'unitOfMeasure': 'percentage of participants (K-M rate)', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated set (all subjects with attempted TAVR procedure according to first device used)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Clinical Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)'}, {'id': 'OG001', 'title': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System'}], 'classes': [{'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000'}, {'value': '30.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Incidence of clinical efficacy (after 30 days) at 12 months defined as a composite of:\n\n* All-cause mortality\n* All stroke (disabling and non-disabling)\n* Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure\n* NYHA class III or IV\n* Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, EOA ≤0.9-1.1 cm2 and/or Doppler velocity index (DVI) \\<0. 35m/s, AND/OR moderate or severe prosthetic valve regurgitation)', 'unitOfMeasure': 'percentage of participants (K-M rate)', 'reportingStatus': 'POSTED', 'populationDescription': 'Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Individual Clinical Endpoint Components Including Mortality, Disabling Stroke and Heart Failure Rehospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)'}, {'id': 'OG001', 'title': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System'}], 'classes': [{'title': 'All Cause Mortality', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '5.9', 'groupId': 'OG001'}]}]}, {'title': 'Disabling Stroke', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Heart Failure Rehospitalization', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '3.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'unitOfMeasure': 'percentage of participants (K-M rate)', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated set (all subjects with attempted TAVR procedure according to first device used)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'New Pacemaker Implantation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)'}, {'id': 'OG001', 'title': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System'}], 'classes': [{'title': '30 Days', 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000'}, {'value': '7.8', 'groupId': 'OG001'}]}]}, {'title': '12-Month', 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days, 12 months', 'description': 'Note: This section is excluding subjects with pacemaker or ICD at baseline.', 'unitOfMeasure': 'percentage of participants (K-M rate)', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated set (all subjects with attempted TAVR procedure according to first device used)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Aortic Valve Re-intervention Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)'}, {'id': 'OG001', 'title': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System'}], 'classes': [{'title': '30 Days', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}]}]}, {'title': '12 Month', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days, 12 months', 'unitOfMeasure': 'percentage of participants (K-M rate)', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated set (all subjects with attempted TAVR procedure according to first device used)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': '6-minute Walk Test (6MWT) Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)'}, {'id': 'OG001', 'title': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System'}], 'classes': [{'categories': [{'measurements': [{'value': '25.5', 'spread': '97.3', 'groupId': 'OG000'}, {'value': '38.1', 'spread': '86.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'unitOfMeasure': 'Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated set (all subjects with attempted TAVR procedure according to first device used)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': '6-minute Walk Test (6MWT) Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)'}, {'id': 'OG001', 'title': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System'}], 'classes': [{'categories': [{'measurements': [{'value': '39.5', 'spread': '100.5', 'groupId': 'OG000'}, {'value': '33.8', 'spread': '94.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Months', 'unitOfMeasure': 'Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated set (all subjects with attempted TAVR procedure according to first device used)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quality of Life (QoL) Change From Baseline (Kansas City Cardiomyopathy Questionnaire [KCCQ]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)'}, {'id': 'OG001', 'title': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System'}], 'classes': [{'categories': [{'measurements': [{'value': '18.0', 'spread': '19.4', 'groupId': 'OG000'}, {'value': '17.7', 'spread': '19.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, selfefficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.\n\n\\*Note: This is the overall summary score for KCCQ.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated set (all subjects with attempted TAVR procedure according to first device used)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quality of Life (QoL) Change From Baseline (Kansas City Cardiomyopathy Questionnaire [KCCQ])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)'}, {'id': 'OG001', 'title': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System'}], 'classes': [{'categories': [{'measurements': [{'value': '20.3', 'spread': '20.3', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '19.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Months', 'description': 'Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, selfefficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated set (all subjects with attempted TAVR procedure according to first device used)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quality of Life (QoL) Change From Baseline (EuroQol- 5 Dimension [EQ-5D])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)'}, {'id': 'OG001', 'title': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System'}], 'classes': [{'title': 'EQ5D Index', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'EQ5D VAS', 'categories': [{'measurements': [{'value': '8.1', 'spread': '19.1', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '19.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'EuroQol Group developed this Quality of Life (QOL) questionnaire referred to as EQ-5D that includes a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.\n\nThe patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The answers given to ED-5D can be converted into EQ-5D index and utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D Index Score is calculated for each study participant and the descriptive statistical summary of the EQ-5D score for the study population is provided. The EQ-5D Visual Analog Scale (VAS) Score is a scale numbered 0 to 100 (0 is the worse health the patient can imagine and 100 is the best health the patient can imagine).\\*', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated set (all subjects with attempted TAVR procedure according to first device used)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quality of Life (QoL) Change From Baseline (EuroQol- 5 Dimension [EQ-5D])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)'}, {'id': 'OG001', 'title': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System'}], 'classes': [{'title': 'EQ5D Index Score', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'EQ5D VAS', 'categories': [{'measurements': [{'value': '8.4', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '19.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Months', 'description': 'EuroQol Group developed this Quality of Life (QOL) questionnaire referred to as EQ-5D that includes a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.\n\nThe patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The answers given to ED-5D can be converted into EQ-5D index and utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D Index Score is calculated for each study participant and the descriptive statistical summary of the EQ-5D score for the study population is provided. The EQ-5D Visual Analog Scale (VAS) Score is a scale numbered 0 to 100 (0 is the worse health the patient can imagine and 100 is the best health the patient can imagine).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated set (all subjects with attempted TAVR procedure according to first device used)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Gradient ≥ 20 mmHg Based on Stress Echocardiogram', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)'}, {'id': 'OG001', 'title': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Mean gradient ≥ 20 mmHg based on stress echocardiogram at select sites.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)'}, {'id': 'FG001', 'title': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Intention to treat (ITT) set according to subject randomization', 'achievements': [{'groupId': 'FG000', 'numSubjects': '366'}, {'groupId': 'FG001', 'numSubjects': '371'}]}, {'type': 'Exited Prior to Procedure', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'ITT (Intention to Treat) Population After Exit Prior to Procedure', 'achievements': [{'groupId': 'FG000', 'numSubjects': '356'}, {'groupId': 'FG001', 'numSubjects': '360'}]}, {'type': 'Administrative Cross-overs', 'comment': 'Administrative cross-over subjects are those with first attempted procedure is with the other treatment device that they were not randomized to. These subjects are analyzed with the other treatment device in the as-treated set.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Attempted With Randomized Device', 'achievements': [{'groupId': 'FG000', 'numSubjects': '354'}, {'groupId': 'FG001', 'numSubjects': '359'}]}, {'type': 'Procedural Cross-overs', 'comment': 'Procedural cross-overs are subjects who were first attempted with one device (per randomization assignment) and implanted with the other device at the time of the index procedure. These subjects are analyzed with the other treatment device in the implanted set.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Implanted with randomized device', 'achievements': [{'groupId': 'FG000', 'numSubjects': '350'}, {'groupId': 'FG001', 'numSubjects': '359'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}], 'preAssignmentDetails': 'A total of 1103 subjects were enrolled (consented): 212 subjects were exited prior to screening,154 exited the study prior to randomization, 737\\* subjects were randomized.\n\n\\*Notes: One additional subject was inadvertently randomized but was withdrawn after screening disapproval.\n\n-716 subjects had an attempted procedure, these subjects are the As-Treated set and are analyzed according to their first attempted device. This includes both administrative and procedural crossovers as shown below.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'BG000'}, {'value': '361', 'groupId': 'BG001'}, {'value': '716', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)'}, {'id': 'BG001', 'title': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.\n\nEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '80.1', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '80.3', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '80.2', 'spread': '6.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Gender Female', 'categories': [{'measurements': [{'value': '312', 'groupId': 'BG000'}, {'value': '309', 'groupId': 'BG001'}, {'value': '621', 'groupId': 'BG002'}]}]}, {'title': 'Gender Male', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Ethnicity of US Only, Unknown number also includes outside of US.', 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '362', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Ethnicity and race are reported only by US sites (SEV TAV n=183; BE TAV n= 184; Total N=367) This is for as treated subjects.\n\n\\*\\*Note\\*\\*: There are 8 SEV subjects and 5 BEV Subjects from US Sites who did not report ethnicity, therefore the total number with ethnicity reported are 175 SEV and 179 BEV.', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '326', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '364', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Ethnicity and race are reported only by US sites (SEV TAV n=183; BE TAV n= 184; Total N=367) For as treated subjects.\n\n\\*\\*NOTE\\*\\*: There are 10 SEV subjects and 5 BEV subjects from US Sites that did not report race, therefore the total subjects are 173 SEV and 179 BEV.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '184', 'groupId': 'BG001'}, {'value': '367', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Portugal', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Finland', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Surface Area', 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '1.8', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '1.8', 'spread': '0.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'm^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'STS Score', 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '3.2', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '3.3', 'spread': '1.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measure Description: The Society of Thoracic Surgeons (STS) Score is a score that represents the risk of operative mortality, major morbidity, and complications for adult cardiac surgeries.\n\nA total STS Score, presented as a risk probability on a scale of 0-100%, is calculated based on patient characteristics. The STS Score is calculated before a patient undergoes the transcatheter aortic valve replacement (TAVR) index procedure in the study, and a higher STS Score means a patient is at higher risk for surgery.', 'unitOfMeasure': 'Percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'STS Category', 'classes': [{'title': 'Count of Participants', 'categories': [{'measurements': [{'value': '355', 'groupId': 'BG000'}, {'value': '361', 'groupId': 'BG001'}, {'value': '716', 'groupId': 'BG002'}]}]}, {'title': '<3', 'categories': [{'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '373', 'groupId': 'BG002'}]}]}, {'title': '[3,5)', 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}]}, {'title': '[5,8)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}, {'title': '≥ 8', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patients are grouped into the following categories based on their STS score:\n\n\\<3, \\[3,5), \\[5,8), ≥ 8', 'unitOfMeasure': 'Participants'}, {'title': 'NYHA (Baseline)', 'classes': [{'categories': [{'title': 'NYHA I', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'NYHA II', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '408', 'groupId': 'BG002'}]}, {'title': 'NYHA III', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '294', 'groupId': 'BG002'}]}, {'title': 'NYHA IV', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'New York Heart Association (NYHA) Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. Class II:Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III:Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'As Treated set (all subjects with attempted TAVR procedure according to first device used)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-15', 'size': 2400266, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-09-30T11:32', 'hasProtocol': True}, {'date': '2023-11-13', 'size': 547833, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-09-30T11:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1103}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2021-01-20', 'resultsFirstSubmitDate': '2024-11-04', 'studyFirstSubmitQcDate': '2021-01-22', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-28', 'studyFirstPostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Device Success', 'timeFrame': '30 days', 'description': 'Device Success is defined as meeting all of the following:\n\nFreedom from mortality AND Correct positioning of a single prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch (PPM) and mean aortic valve gradient \\<20 mmHg or peak velocity \\<3 m/s) AND No moderate or severe prosthetic valve regurgitation)'}, {'measure': 'Incidence of an Early Safety Composite', 'timeFrame': '30 days', 'description': 'Incidence of an early safety composite at 30 days defined as:\n\n* All-cause mortality\n* All stroke (disabling and non-disabling)\n* Life-threatening bleeding\n* Acute kidney injury-Stage 2 or 3 (including renal replacement therapy)\n* Coronary artery obstruction requiring intervention\n* Major vascular complication\n* Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)'}, {'measure': 'Hospital Readmission Rate for Any Cause', 'timeFrame': '30 days'}, {'measure': 'Incidence of Clinical Efficacy', 'timeFrame': '12 months', 'description': 'Incidence of clinical efficacy (after 30 days) at 12 months defined as a composite of:\n\n* All-cause mortality\n* All stroke (disabling and non-disabling)\n* Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure\n* NYHA class III or IV\n* Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, EOA ≤0.9-1.1 cm2 and/or Doppler velocity index (DVI) \\<0. 35m/s, AND/OR moderate or severe prosthetic valve regurgitation)'}, {'measure': 'Percentage of Participants With Individual Clinical Endpoint Components Including Mortality, Disabling Stroke and Heart Failure Rehospitalization', 'timeFrame': '12 months'}, {'measure': 'New Pacemaker Implantation Rate', 'timeFrame': '30 days, 12 months', 'description': 'Note: This section is excluding subjects with pacemaker or ICD at baseline.'}, {'measure': 'Aortic Valve Re-intervention Rate', 'timeFrame': '30 days, 12 months'}, {'measure': '6-minute Walk Test (6MWT) Change From Baseline', 'timeFrame': '30 days'}, {'measure': '6-minute Walk Test (6MWT) Change From Baseline', 'timeFrame': '12 Months'}, {'measure': 'Quality of Life (QoL) Change From Baseline (Kansas City Cardiomyopathy Questionnaire [KCCQ]', 'timeFrame': '30 days', 'description': 'Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, selfefficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.\n\n\\*Note: This is the overall summary score for KCCQ.'}, {'measure': 'Quality of Life (QoL) Change From Baseline (Kansas City Cardiomyopathy Questionnaire [KCCQ])', 'timeFrame': '12 Months', 'description': 'Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, selfefficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.'}, {'measure': 'Quality of Life (QoL) Change From Baseline (EuroQol- 5 Dimension [EQ-5D])', 'timeFrame': '30 days', 'description': 'EuroQol Group developed this Quality of Life (QOL) questionnaire referred to as EQ-5D that includes a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.\n\nThe patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The answers given to ED-5D can be converted into EQ-5D index and utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D Index Score is calculated for each study participant and the descriptive statistical summary of the EQ-5D score for the study population is provided. The EQ-5D Visual Analog Scale (VAS) Score is a scale numbered 0 to 100 (0 is the worse health the patient can imagine and 100 is the best health the patient can imagine).\\*'}, {'measure': 'Quality of Life (QoL) Change From Baseline (EuroQol- 5 Dimension [EQ-5D])', 'timeFrame': '12 Months', 'description': 'EuroQol Group developed this Quality of Life (QOL) questionnaire referred to as EQ-5D that includes a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.\n\nThe patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The answers given to ED-5D can be converted into EQ-5D index and utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D Index Score is calculated for each study participant and the descriptive statistical summary of the EQ-5D score for the study population is provided. The EQ-5D Visual Analog Scale (VAS) Score is a scale numbered 0 to 100 (0 is the worse health the patient can imagine and 100 is the best health the patient can imagine).'}, {'measure': 'Mean Gradient ≥ 20 mmHg Based on Stress Echocardiogram', 'timeFrame': '12 months', 'description': 'Mean gradient ≥ 20 mmHg based on stress echocardiogram at select sites.'}], 'primaryOutcomes': [{'measure': 'Mortality, Disabling Stroke or Heart Failure Rehospitalization', 'timeFrame': '12 months', 'description': 'Percentage of participants with all-cause mortality, disabling stroke, or heart failure rehospitalization.'}, {'measure': 'Bioprosthetic Valve Dysfunction (BVD)', 'timeFrame': '12 months', 'description': 'Percentage of participants with BVD (hemodynamic structural valve dysfunction (hemodynamic mean gradient ≥ 20mmHg), non-structural valve dysfunction (severe prosthesis-patient mismatch and/or ≥ moderate total aortic regurgitation), thrombosis, endocarditis, or aortic valve re-intervention) at 12 months.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With BVD in Female Subjects', 'timeFrame': '12 months'}, {'measure': 'Percentage of Participants With Hemodynamic Structural Valve Dysfunction (HSVD)', 'timeFrame': '12 months', 'description': 'HSVD is defined as hemodynamic mean gradient ≥ 20mmHg on any echocardiogram after implant procedure.'}, {'measure': 'Hemodynamic Mean Gradient as Continuous Variable', 'timeFrame': '12 months', 'description': 'Mean aortic gradient as measured by echocardiogram at the 12-month visit.'}, {'measure': 'Effective Orifice Area (EOA) as a Continuous Variable', 'timeFrame': '12 months', 'description': 'Effective Orifice Area (EOA) as measured by echocardiogram at the 12-month visit.'}, {'measure': 'Rate of Moderate or Severe Prothesis-patient Mismatch (PPM)', 'timeFrame': '30 days', 'description': 'Moderate or severe PPM will be defined as follows:\n\nFor subjects with BMI \\< 30 kg/m2\n\n* Moderate PPM: EOAI = 0.85 - 0.65 cm2/m2\n* Severe PPM: EOAI = ≤ 0.65 cm2/m2\n\nFor subjects with BMI ≥ 30 kg/m2\n\n* Moderate PPM: EOAI = 0.70 - 0.55 cm2/m2\n* Severe PPM: EOAI = ≤ 0.55 cm2/m2'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Symptomatic Aortic Stenosis', 'Aortic Valve Stenosis', 'Aortic Valve Replacement']}, 'referencesModule': {'references': [{'pmid': '39382856', 'type': 'DERIVED', 'citation': 'Tchetche D, Mehran R, Blackman DJ, Khalil RF, Mollmann H, Abdel-Wahab M, Ben Ali W, Mahoney PD, Ruge H, Bleiziffer S, Lin L, Szerlip M, Grubb KJ, Byku I, Guerrero M, Gillam LD, Petronio AS, Attizzani GF, Batchelor WB, Gada H, Rogers T, Rovin JD, Whisenant B, Benton S, Gardner B, Padang R, Althouse AD, Herrmann HC. Transcatheter Aortic Valve Implantation by Valve Type in Women With Small Annuli: Results From the SMART Randomized Clinical Trial. JAMA Cardiol. 2024 Dec 1;9(12):1106-1114. doi: 10.1001/jamacardio.2024.3241.'}, {'pmid': '38587261', 'type': 'DERIVED', 'citation': 'Herrmann HC, Mehran R, Blackman DJ, Bailey S, Mollmann H, Abdel-Wahab M, Ben Ali W, Mahoney PD, Ruge H, Wood DA, Bleiziffer S, Ramlawi B, Gada H, Petronio AS, Resor CD, Merhi W, Garcia Del Blanco B, Attizzani GF, Batchelor WB, Gillam LD, Guerrero M, Rogers T, Rovin JD, Szerlip M, Whisenant B, Deeb GM, Grubb KJ, Padang R, Fan MT, Althouse AD, Tchetche D; SMART Trial Investigators. Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus. N Engl J Med. 2024 Jun 6;390(21):1959-1971. doi: 10.1056/NEJMoa2312573. Epub 2024 Apr 7.'}, {'pmid': '34587510', 'type': 'DERIVED', 'citation': 'Herrmann HC, Abdel-Wahab M, Attizzani GF, Batchelor W, Bleiziffer S, Verdoliva S, Chang Y, Gada H, Gillam L, Guerrero M, Mahoney PD, Petronio AS, Rogers T, Rovin J, Szerlip M, Whisenant B, Mehran R, Tchetche D. Rationale and design of the SMall Annuli Randomized To Evolut or SAPIEN Trial (SMART Trial). Am Heart J. 2022 Jan;243:92-102. doi: 10.1016/j.ahj.2021.09.011. Epub 2021 Sep 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis.\n\nAdditionally, a stress echocardiography sub-study will be conducted as part of the SMART Trial at select sites. The purpose of the sub-study is to evaluate performance of SE versus BE TAVR in subjects with a small aortic annulus and symptomatic severe native aortic stenosis after undergoing exercise stress echocardiographic testing.', 'detailedDescription': 'This is a prospective, multi-center, international, randomized controlled, post-market trial.\n\nThe primary objectives of the trial are to demonstrate clinical non-inferiority and hemodynamic superiority of the Evolut PRO/PRO+/FX System when compared to subjects treated with the SAPIEN 3/3 Ultra System at 12 months post-procedure.\n\nSubjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE Transcatheter Aortic Valve (TAV) or an Edwards BE Transcatheter Heart Valve (THV). Data will be collected at pre- and post-procedure, at discharge, at 30 days, and once a year until the 5-year follow-up is completed.\n\nProduct Names:\n\n* Medtronic Evolut PRO and Evolut PRO+ TAV Systems, Evolut FX System (Commercially available in the United States and may be used upon commercial availability in Canada.)\n* Edwards SAPIEN 3 and SAPIEN 3 Ultra THV Systems\n\nThe exercise stress echocardiographic testing at select SMART Trial sites seeks to evaluate the performance of the prosthetic aortic valve during exercise. The stress echocardiogram assessment will be conducted as part of the 12-month visit for participating subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Heart Team agrees that the subject is deemed symptomatic and is a candidate for transcatheter aortic valve replacement (TAVR)\n* Subject has a predicted risk of operative mortality \\< 15% as determined by the local Heart Team\n* Subject has severe aortic stenosis as determined by transthoracic echocardiography (TTE) at rest\n* Subject has a small aortic annulus as determined by Multi-detector computed tomography (MDCT)\n* Subject's anatomy is appropriate for both Medtronic Evolut PRO/PRO+/FX TAV and Edwards SAPIEN 3/3 Ultra TAV\n* Subject's anatomy is suitable for TAVR via transfemoral vessel access\n* Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits\n\nExclusion Criteria:\n\n* Estimated life expectancy of fewer than 2 years\n* Multivessel coronary artery disease with a Syntax score \\>32 and/or unprotected left main coronary artery(Syntax score calculation is not required for patients with history of previous revascularization if repeat revascularization is not planned).\n* Participating in another trial that may influence the outcome of this trial\n* Need for an emergent procedure for any reason\n* Contraindicated for treatment with the Evolut PRO/PRO+/FX and Edwards SAPIEN 3/3 Ultra TAV in accordance with the Instructions for Use\n* Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams\n* Pregnant, nursing, or planning to be pregnant\n* Subject is less than the legal age of consent, legally incompetent, unable to provide his/her own informed consent, or otherwise vulnerable\n* Subject has an active COVID-19 infection or relevant history of COVID-19\n* Previous aortic valve replacement"}, 'identificationModule': {'nctId': 'NCT04722250', 'acronym': 'SMART', 'briefTitle': 'SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiovascular'}, 'officialTitle': 'SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial', 'orgStudyIdInfo': {'id': 'MDT20023EVR012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medtronic Self-Expanding TAV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.', 'interventionNames': ['Device: Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems']}, {'type': 'EXPERIMENTAL', 'label': 'Edwards Balloon-Expandable THV', 'description': 'Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic 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