Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-04 @ 9:36 AM
Study NCT ID:
NCT00530894
Status:
COMPLETED
Last Update Posted:
2017-09-13
First Post:
2007-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tenley_koepnick@edwards.com', 'phone': '949-250-6504', 'title': 'Tenley Koepnick', 'organization': 'Edwards Lifesciences'}, 'certainAgreement': {'otherDetails': 'Site cannot publish or present on overall study results not yet published. PI may publish his own clinical study data subject to EW review prior submission or presentation, but data analyses of site-specific results can occur only in intervals as specified in the CSA.\n\nPublication of site-specific results cannot include claims of device safety and effectiveness and requires EW review.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 Year', 'eventGroups': [{'id': 'EG000', 'title': 'High Risk: TAVR', 'description': 'Edwards SAPIEN Transcatheter Heart Valve', 'otherNumAtRisk': 348, 'otherNumAffected': 230, 'seriousNumAtRisk': 348, 'seriousNumAffected': 228}, {'id': 'EG001', 'title': 'High Risk: SAVR', 'description': 'Surgical Aortic Valve Replacement', 'otherNumAtRisk': 351, 'otherNumAffected': 217, 'seriousNumAtRisk': 351, 'seriousNumAffected': 238}, {'id': 'EG002', 'title': 'Inoperable: TAVR', 'description': 'Edwards SAPIEN Transcatheter Heart Valve', 'otherNumAtRisk': 179, 'otherNumAffected': 140, 'seriousNumAtRisk': 179, 'seriousNumAffected': 134}, {'id': 'EG003', 'title': 'Inoperable: Medical Therapy', 'description': 'Medical management and/or balloon aortic valvuloplasty', 'otherNumAtRisk': 179, 'otherNumAffected': 103, 'seriousNumAtRisk': 179, 'seriousNumAffected': 151}], 'otherEvents': [{'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 242, 'numAffected': 133}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 219, 'numAffected': 124}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 204, 'numAffected': 87}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 80, 'numAffected': 44}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abnormal Lab Values', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 128, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 136, 'numAffected': 84}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 86, 'numAffected': 51}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 46, 'numAffected': 28}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Infection (including Endocarditis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 80, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 69, 'numAffected': 58}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 57, 'numAffected': 44}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 52, 'numAffected': 34}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 49, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 88, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 30, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Respiratory Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 38, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 35, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bleeding event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 25, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hemorrhagic/Vascular event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 25, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 25, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 52, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastro-Intestinal Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 29, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CHF', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 28, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Renal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Neurological event (including TIA stroke and psychomotor deficit)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 127, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 129, 'numAffected': 86}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 98, 'numAffected': 60}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 105, 'numAffected': 68}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 1+E21+E16:E40'}, {'term': 'Infection (including Endocarditis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 96, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 74, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 53, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 38, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CHF', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 73, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 64, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 32, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 102, 'numAffected': 78}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Respiratory Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 66, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 76, 'numAffected': 61}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 28, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 23, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bleeding event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 33, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 42, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 26, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'STS/FDA'}, {'term': 'Neurological event (including TIA stroke and psychomotor deficit)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 28, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 28, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'STS/AATS'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 34, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 44, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 32, 'numAffected': 24}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastro-Intestinal Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hemorrhagic/Vascular event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 29, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abnormal Lab Values', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 17, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Conduction defects', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Renal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Device embolization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Aortic insufficiency without paravalvular leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'MI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Perforation or damage to myocardium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Device migration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Electrolyte Imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Perivalvular leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 42, 'numAffected': 33}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Mitral insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Access site nerve injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 351, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 179, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 179, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk: TAVR', 'description': 'Edwards SAPIEN Transcatheter Heart Valve'}, {'id': 'OG001', 'title': 'High Risk: SAVR', 'description': 'Surgical Aortic Valve Replacement'}, {'id': 'OG002', 'title': 'Inoperable: TAVR', 'description': 'Edwards SAPIEN Transcatheter Heart Valve'}, {'id': 'OG003', 'title': 'Inoperable: Medical Therapy', 'description': 'Medical management and/or balloon aortic valvuloplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 Year', 'description': 'Death from any cause.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Composite of Death and Recurrence Hospitalization.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inoperable: TAVR', 'description': 'Edwards SAPIEN Transcatheter Heart Valve'}, {'id': 'OG001', 'title': 'Inoperable: Medical Therapy', 'description': 'Medical management and/or balloon aortic valvuloplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'duration of study', 'description': 'Death from any cause or repeat hospitalization after intervention.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Composite of Death and recurrence hospitalization was not a primary outcome for the High Risk groups.'}, {'type': 'SECONDARY', 'title': 'Functional Change of NYHA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}, {'value': '167', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk: TAVR', 'description': 'Edwards SAPIEN Transcatheter Heart Valve'}, {'id': 'OG001', 'title': 'High Risk: SAVR', 'description': 'Surgical Aortic Valve Replacement'}, {'id': 'OG002', 'title': 'Inoperable: TAVR', 'description': 'Edwards SAPIEN Transcatheter Heart Valve'}, {'id': 'OG003', 'title': 'Inoperable: Medical Therapy', 'description': 'Medical management and/or balloon aortic valvuloplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '2.50', 'groupId': 'OG000', 'lowerLimit': '2.35', 'upperLimit': '2.65'}, {'value': '2.60', 'groupId': 'OG001', 'lowerLimit': '2.45', 'upperLimit': '2.76'}, {'value': '2.88', 'groupId': 'OG002', 'lowerLimit': '2.70', 'upperLimit': '3.07'}, {'value': '3.92', 'groupId': 'OG003', 'lowerLimit': '3.73', 'upperLimit': '4.11'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 1 year', 'description': 'NYHA classification change from baseline to 1 year visit. NYHA provides a way of classifying the extent of heart failure. New York Heart Association (NYHA) is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.', 'unitOfMeasure': 'Units on scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Major Adverse Cardiac and Cerebro-vascular Events (MACCE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk: TAVR', 'description': 'Edwards SAPIEN Transcatheter Heart Valve'}, {'id': 'OG001', 'title': 'High Risk: SAVR', 'description': 'Surgical Aortic Valve Replacement'}, {'id': 'OG002', 'title': 'Inoperable: TAVR', 'description': 'Edwards SAPIEN Transcatheter Heart Valve'}, {'id': 'OG003', 'title': 'Inoperable: Medical Therapy', 'description': 'Medical management and/or balloon aortic valvuloplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Number of participants with MACCE definition includes death, myocardial infarction (MI), stroke and renal failure', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Hospital Days From the Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk: TAVR', 'description': 'Edwards SAPIEN Transcatheter Heart Valve'}, {'id': 'OG001', 'title': 'High Risk: SAVR', 'description': 'Surgical Aortic Valve Replacement'}, {'id': 'OG002', 'title': 'Inoperable: TAVR', 'description': 'Edwards SAPIEN Transcatheter Heart Valve'}, {'id': 'OG003', 'title': 'Inoperable: Medical Therapy', 'description': 'Medical management and/or balloon aortic valvuloplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '17.42', 'spread': '19.05', 'groupId': 'OG000'}, {'value': '20.14', 'spread': '23.85', 'groupId': 'OG001'}, {'value': '25.24', 'spread': '21.11', 'groupId': 'OG002'}, {'value': '17.04', 'spread': '33.46', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Total hospital days from the index procedure or randomization into control arm to one year post procedure or randomization.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life (QOL) From Baseline to 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk: TAVR', 'description': 'Edwards SAPIEN Transcatheter Heart Valve'}, {'id': 'OG001', 'title': 'High Risk: SAVR', 'description': 'Surgical Aortic Valve Replacement'}, {'id': 'OG002', 'title': 'Inoperable: TAVR', 'description': 'Edwards SAPIEN Transcatheter Heart Valve'}, {'id': 'OG003', 'title': 'Inoperable: Medical Therapy', 'description': 'Medical management and/or balloon aortic valvuloplasty'}], 'classes': [{'title': 'KCCQ Overall', 'categories': [{'measurements': [{'value': '70.0', 'spread': '22.4', 'groupId': 'OG000'}, {'value': '71.1', 'spread': '23.0', 'groupId': 'OG001'}, {'value': '69.41', 'spread': '25.37', 'groupId': 'OG002'}, {'value': '46.98', 'spread': '24.59', 'groupId': 'OG003'}]}]}, {'title': 'SF-12 Physical', 'categories': [{'measurements': [{'value': '36.3', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '36.9', 'spread': '10.4', 'groupId': 'OG001'}, {'value': '34.85', 'spread': '11.13', 'groupId': 'OG002'}, {'value': '29.68', 'spread': '6.47', 'groupId': 'OG003'}]}]}, {'title': 'SF-12 Mental', 'categories': [{'measurements': [{'value': '52.0', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '52.9', 'spread': '9.7', 'groupId': 'OG001'}, {'value': '53.31', 'spread': '10.00', 'groupId': 'OG002'}, {'value': '46.59', 'spread': '11.68', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 Year', 'description': 'The QOL questionnaire consisted of: Kansas City Cardiomyopathy (KCCQ), The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states.\n\nKCCQ scores are on a range of 0-100, in which 100 reflects the best health status and 0 reflects the worst health status.\n\nSF-12 questionnaire was used in which 100 reflects the best health status and 0 reflects the worst health status.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Risk: TAVR', 'description': 'Edwards SAPIEN Transcatheter Heart Valve'}, {'id': 'FG001', 'title': 'High Risk: SAVR', 'description': 'Surgical Aortic Valve Replacement'}, {'id': 'FG002', 'title': 'Inoperable: TAVR', 'description': 'Edwards SAPIEN Transcatheter Heart Valve'}, {'id': 'FG003', 'title': 'Inoperable: Medical Therapy', 'description': 'Medical management and/or balloon aortic valvuloplasty'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '348'}, {'groupId': 'FG001', 'numSubjects': '351'}, {'groupId': 'FG002', 'numSubjects': '179'}, {'groupId': 'FG003', 'numSubjects': '179'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '260'}, {'groupId': 'FG001', 'numSubjects': '236'}, {'groupId': 'FG002', 'numSubjects': '124'}, {'groupId': 'FG003', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '115'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '94'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '89'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Alive and censored prior to 1 year', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'BG000'}, {'value': '349', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}, {'value': '1055', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'High Risk: TAVR', 'description': 'Edwards SAPIEN Transcatheter Heart Valve'}, {'id': 'BG001', 'title': 'High Risk: SAVR', 'description': 'Surgical Valve Replacement'}, {'id': 'BG002', 'title': 'Inoperable TAVR', 'description': 'Edwards SAPIEN Transcatheter Heart Valve'}, {'id': 'BG003', 'title': 'Inoperable: Medical Therapy', 'description': 'Medical management and/or balloon aortic valvuloplasty'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'High Risk', 'categories': [{'measurements': [{'value': '83.61', 'spread': '6.83', 'groupId': 'BG000'}, {'value': '84.52', 'spread': '6.37', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG003'}, {'value': '84.11', 'spread': '6.61', 'groupId': 'BG004'}]}]}, {'title': 'Inoperable', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG001'}, {'value': '83.12', 'spread': '8.60', 'groupId': 'BG002'}, {'value': '83.18', 'spread': '8.29', 'groupId': 'BG003'}, {'value': '83.18', 'spread': '8.43', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}, {'value': '490', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '201', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}, {'value': '565', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '324', 'groupId': 'BG000'}, {'value': '328', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}, {'value': '162', 'groupId': 'BG003'}, {'value': '979', 'groupId': 'BG004'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'NYHA Class', 'classes': [{'title': 'High Risk Class II', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}]}, {'title': 'Operable Class II', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}]}, {'title': 'High Risk Class III or IV', 'categories': [{'measurements': [{'value': '328', 'groupId': 'BG000'}, {'value': '328', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG003'}, {'value': '656', 'groupId': 'BG004'}]}]}, {'title': 'Inoperable Class III or IV', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}, {'value': '168', 'groupId': 'BG003'}, {'value': '333', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort.', 'unitOfMeasure': 'Participants'}, {'title': 'Quality of Life', 'classes': [{'title': 'High Risk KCCQ Overall', 'categories': [{'measurements': [{'value': '39.6', 'spread': '21.8', 'groupId': 'BG000'}, {'value': '44.5', 'spread': '21.8', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG003'}, {'value': '41.88', 'spread': '21.93', 'groupId': 'BG004'}]}]}, {'title': 'Inoperable KCCQ Overall', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG001'}, {'value': '36.19', 'spread': '20.52', 'groupId': 'BG002'}, {'value': '34.44', 'spread': '20.14', 'groupId': 'BG003'}, {'value': '35.35', 'spread': '20.32', 'groupId': 'BG004'}]}]}, {'title': 'High Risk SF-12 Physical', 'categories': [{'measurements': [{'value': '29.6', 'spread': '7.6', 'groupId': 'BG000'}, {'value': '30.9', 'spread': '8.2', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG003'}, {'value': '30.2', 'spread': '7.9', 'groupId': 'BG004'}]}]}, {'title': 'Inoperable SF-12 Physical', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG001'}, {'value': '28.23', 'spread': '7.73', 'groupId': 'BG002'}, {'value': '27.70', 'spread': '6.89', 'groupId': 'BG003'}, {'value': '28.0', 'spread': '7.23', 'groupId': 'BG004'}]}]}, {'title': 'High Risk SF-12 Mental', 'categories': [{'measurements': [{'value': '46.9', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '47.6', 'spread': '10.7', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG003'}, {'value': '47.2', 'spread': '11.1', 'groupId': 'BG004'}]}]}, {'title': 'Inoperable SF-12 Mental', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG001'}, {'value': '44.45', 'spread': '12.16', 'groupId': 'BG002'}, {'value': '45.23', 'spread': '11.03', 'groupId': 'BG003'}, {'value': '44.84', 'spread': '11.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The QOL questionnaire consisted of: Kansas City Cardiomyopathy (KCCQ), EuroQOL, SF-12. The QOL questionnaire consisted of: Kansas City Cardiomyopathy (KCCQ), The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states. KCCQ scores are on a range of 0-100, in which 100 reflects the best health status and 0 reflects the worst health status. SF-12 questionnaire was used in which 100 reflects the best health status and 0 reflects the worst health status.', 'unitOfMeasure': 'Score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'STS Score', 'classes': [{'title': 'High Risk', 'categories': [{'measurements': [{'value': '11.8', 'spread': '3.3', 'groupId': 'BG000'}, {'value': '11.7', 'spread': '3.5', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG003'}, {'value': '11.75', 'spread': '3.40', 'groupId': 'BG004'}]}]}, {'title': 'Inoperable', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials', 'groupId': 'BG001'}, {'value': '11.2', 'spread': '5.8', 'groupId': 'BG002'}, {'value': '11.9', 'spread': '4.8', 'groupId': 'BG003'}, {'value': '11.51', 'spread': '5.34', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The Society of Thoracic Surgeons (STS) score measures patient risk at the time of cardiovascular surgery on a scale that ranges from 0% to 100%, with higher numbers indicating greater risk.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The inoperable and high risk groups were not randomized against each other and were essentially two separate trials, therefore the pooled mean and standard deviations do not provide meaningful data and were not reported.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1057}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-14', 'studyFirstSubmitDate': '2007-09-14', 'resultsFirstSubmitDate': '2016-03-07', 'studyFirstSubmitQcDate': '2007-09-14', 'lastUpdatePostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-03', 'studyFirstPostDateStruct': {'date': '2007-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death', 'timeFrame': '1 Year', 'description': 'Death from any cause.'}, {'measure': 'Composite of Death and Recurrence Hospitalization.', 'timeFrame': 'duration of study', 'description': 'Death from any cause or repeat hospitalization after intervention.'}], 'secondaryOutcomes': [{'measure': 'Functional Change of NYHA', 'timeFrame': 'Baseline to 1 year', 'description': 'NYHA classification change from baseline to 1 year visit. NYHA provides a way of classifying the extent of heart failure. New York Heart Association (NYHA) is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.'}, {'measure': 'Number of Participants With Major Adverse Cardiac and Cerebro-vascular Events (MACCE)', 'timeFrame': '1 year', 'description': 'Number of participants with MACCE definition includes death, myocardial infarction (MI), stroke and renal failure'}, {'measure': 'Total Hospital Days From the Index Procedure', 'timeFrame': '1 year', 'description': 'Total hospital days from the index procedure or randomization into control arm to one year post procedure or randomization.'}, {'measure': 'Change in Quality of Life (QOL) From Baseline to 1 Year', 'timeFrame': 'Baseline and 1 Year', 'description': 'The QOL questionnaire consisted of: Kansas City Cardiomyopathy (KCCQ), The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states.\n\nKCCQ scores are on a range of 0-100, in which 100 reflects the best health status and 0 reflects the worst health status.\n\nSF-12 questionnaire was used in which 100 reflects the best health status and 0 reflects the worst health status.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Valvular Heart Disease', 'Critical/Severe Aortic Stenosis', 'High risk symptomatic patients'], 'conditions': ['Critical Aortic Stenosis']}, 'referencesModule': {'references': [{'pmid': '36538580', 'type': 'DERIVED', 'citation': 'Huded CP, Arnold SV, Chhatriwalla AK, Saxon JT, Kapadia S, Yu X, Webb JG, Thourani VH, Kodali SK, Smith CR, Mack MJ, Leon MB, Cohen DJ. Rehospitalization Events After Aortic Valve Replacement: Insights From the PARTNER Trial. Circ Cardiovasc Interv. 2022 Dec;15(12):e012195. doi: 10.1161/CIRCINTERVENTIONS.122.012195. Epub 2022 Dec 20.'}, {'pmid': '35656983', 'type': 'DERIVED', 'citation': 'Shahim B, Redfors B, Lindman BR, Chen S, Dahlen T, Nazif T, Kapadia S, Gertz ZM, Crowley AC, Li D, Thourani VH, Kodali SK, Zajarias A, Babaliaros VC, Guyton RA, Elmariah S, Herrmann HC, Cohen DJ, Mack MJ, Smith CR, Leon MB, George I. Neutrophil-to-Lymphocyte Ratios in Patients Undergoing Aortic Valve Replacement: The PARTNER Trials and Registries. J Am Heart Assoc. 2022 Jun 7;11(11):e024091. doi: 10.1161/JAHA.121.024091. Epub 2022 Jun 3.'}, {'pmid': '35041482', 'type': 'DERIVED', 'citation': 'Vincent F, Thourani VH, Ternacle J, Redfors B, Cohen DJ, Hahn RT, Li D, Crowley A, Webb JG, Mack MJ, Kapadia S, Russo M, Smith CR, Alu MC, Leon MB, Pibarot P. 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Epub 2015 Mar 15.'}, {'pmid': '25788231', 'type': 'DERIVED', 'citation': 'Kapadia SR, Leon MB, Makkar RR, Tuzcu EM, Svensson LG, Kodali S, Webb JG, Mack MJ, Douglas PS, Thourani VH, Babaliaros VC, Herrmann HC, Szeto WY, Pichard AD, Williams MR, Fontana GP, Miller DC, Anderson WN, Akin JJ, Davidson MJ, Smith CR; PARTNER trial investigators. 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet. 2015 Jun 20;385(9986):2485-91. doi: 10.1016/S0140-6736(15)60290-2. Epub 2015 Mar 15.'}, {'pmid': '25700756', 'type': 'DERIVED', 'citation': 'Kapadia S, Stewart WJ, Anderson WN, Babaliaros V, Feldman T, Cohen DJ, Douglas PS, Makkar RR, Svensson LG, Webb JG, Wong SC, Brown DL, Miller DC, Moses JW, Smith CR, Leon MB, Tuzcu EM. Outcomes of inoperable symptomatic aortic stenosis patients not undergoing aortic valve replacement: insight into the impact of balloon aortic valvuloplasty from the PARTNER trial (Placement of AoRtic TraNscathetER Valve trial). JACC Cardiovasc Interv. 2015 Feb;8(2):324-333. doi: 10.1016/j.jcin.2014.08.015.'}, {'pmid': '25616819', 'type': 'DERIVED', 'citation': 'Nazif TM, Dizon JM, Hahn RT, Xu K, Babaliaros V, Douglas PS, El-Chami MF, Herrmann HC, Mack M, Makkar RR, Miller DC, Pichard A, Tuzcu EM, Szeto WY, Webb JG, Moses JW, Smith CR, Williams MR, Leon MB, Kodali SK; PARTNER Publications Office. Predictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve replacement: the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry. JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):60-9. doi: 10.1016/j.jcin.2014.07.022.'}, {'pmid': '25586156', 'type': 'DERIVED', 'citation': 'Passeri JJ, Elmariah S, Xu K, Inglessis I, Baker JN, Alu M, Kodali S, Leon MB, Svensson LG, Pibarot P, Fearon WF, Kirtane AJ, Vlahakes GJ, Palacios IF, Douglas PS; PARTNER Investigators. Transcatheter aortic valve replacement and standard therapy in inoperable patients with aortic stenosis and low EF. Heart. 2015 Mar;101(6):463-71. doi: 10.1136/heartjnl-2014-306737. Epub 2015 Jan 13.'}, {'pmid': '25524339', 'type': 'DERIVED', 'citation': 'Genereux P, Cohen DJ, Mack M, Rodes-Cabau J, Yadav M, Xu K, Parvataneni R, Hahn R, Kodali SK, Webb JG, Leon MB. Incidence, predictors, and prognostic impact of late bleeding complications after transcatheter aortic valve replacement. J Am Coll Cardiol. 2014 Dec 23;64(24):2605-2615. doi: 10.1016/j.jacc.2014.08.052.'}, {'pmid': '25459036', 'type': 'DERIVED', 'citation': 'Fearon WF, Kodali S, Doshi D, Fischbein MP, Yeung AC, Tuzcu EM, Rihal CS, Babaliaros V, Zajarias A, Herrmann HC, Brown DL, Mack M, Teirstein PS, Whisenant BK, Makkar R, Kapadia S, Leon MB; PARTNER Trial Investigators. Outcomes after transfemoral transcatheter aortic valve replacement: a comparison of the randomized PARTNER (Placement of AoRTic TraNscathetER Valves) trial with the NRCA (Nonrandomized Continued Access) registry. JACC Cardiovasc Interv. 2014 Nov;7(11):1245-51. doi: 10.1016/j.jcin.2014.05.033. Epub 2014 Nov 17.'}, {'pmid': '25455544', 'type': 'DERIVED', 'citation': 'Douglas PS, Hahn RT, Pibarot P, Weissman NJ, Stewart WJ, Xu K, Wang Z, Lerakis S, Siegel R, Thompson C, Gopal D, Keane MG, Svensson LG, Tuzcu EM, Smith CR, Leon MB. Hemodynamic outcomes of transcatheter aortic valve replacement and medical management in severe, inoperable aortic stenosis: a longitudinal echocardiographic study of cohort B of the PARTNER trial. J Am Soc Echocardiogr. 2015 Feb;28(2):210-7.e1-9. doi: 10.1016/j.echo.2014.10.009. Epub 2014 Nov 20.'}, {'pmid': '25336467', 'type': 'DERIVED', 'citation': 'Arnold SV, Lei Y, Reynolds MR, Magnuson EA, Suri RM, Tuzcu EM, Petersen JL 2nd, Douglas PS, Svensson LG, Gada H, Thourani VH, Kodali SK, Mack MJ, Leon MB, Cohen DJ; PARTNER Investigators. Costs of periprocedural complications in patients treated with transcatheter aortic valve replacement: results from the Placement of Aortic Transcatheter Valve trial. Circ Cardiovasc Interv. 2014 Dec;7(6):829-36. doi: 10.1161/CIRCINTERVENTIONS.114.001395. Epub 2014 Oct 21.'}, {'pmid': '25270901', 'type': 'DERIVED', 'citation': 'Rodes-Cabau J, Pibarot P, Suri RM, Kodali S, Thourani VH, Szeto WY, Svensson LG, Dumont E, Xu K, Hahn RT, Leon MB. 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Comprehensive analysis of mortality among patients undergoing TAVR: results of the PARTNER trial. J Am Coll Cardiol. 2014 Jul 15;64(2):158-68. doi: 10.1016/j.jacc.2013.08.1666.'}, {'pmid': '24958751', 'type': 'DERIVED', 'citation': 'Arnold SV, Reynolds MR, Lei Y, Magnuson EA, Kirtane AJ, Kodali SK, Zajarias A, Thourani VH, Green P, Rodes-Cabau J, Beohar N, Mack MJ, Leon MB, Cohen DJ; PARTNER Investigators. Predictors of poor outcomes after transcatheter aortic valve replacement: results from the PARTNER (Placement of Aortic Transcatheter Valve) trial. Circulation. 2014 Jun 24;129(25):2682-90. doi: 10.1161/CIRCULATIONAHA.113.007477. Epub 2014 May 23.'}, {'pmid': '24820191', 'type': 'DERIVED', 'citation': "Beohar N, Whisenant B, Kirtane AJ, Leon MB, Tuzcu EM, Makkar R, Svensson LG, Miller DC, Smith CR, Pichard AD, Herrmann HC, Thourani VH, Szeto WY, Lim S, Fischbein M, Fearon WF, O'Neill W, Xu K, Dewey T, Mack M. The relative performance characteristics of the logistic European System for Cardiac Operative Risk Evaluation score and the Society of Thoracic Surgeons score in the Placement of Aortic Transcatheter Valves trial. J Thorac Cardiovasc Surg. 2014 Dec;148(6):2830-7.e1. doi: 10.1016/j.jtcvs.2014.04.006. Epub 2014 Apr 13."}, {'pmid': '24561149', 'type': 'DERIVED', 'citation': 'Williams M, Kodali SK, Hahn RT, Humphries KH, Nkomo VT, Cohen DJ, Douglas PS, Mack M, McAndrew TC, Svensson L, Thourani VH, Tuzcu EM, Weissman NJ, Kirtane AJ, Leon MB. Sex-related differences in outcomes after transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis: Insights from the PARTNER Trial (Placement of Aortic Transcatheter Valve). J Am Coll Cardiol. 2014 Apr 22;63(15):1522-8. doi: 10.1016/j.jacc.2014.01.036. 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Impact of preoperative moderate/severe mitral regurgitation on 2-year outcome after transcatheter and surgical aortic valve replacement: insight from the Placement of Aortic Transcatheter Valve (PARTNER) Trial Cohort A. Circulation. 2013 Dec 24;128(25):2776-84. doi: 10.1161/CIRCULATIONAHA.113.003885. Epub 2013 Oct 23.'}, {'pmid': '24140659', 'type': 'DERIVED', 'citation': 'Dvir D, Waksman R, Barbash IM, Kodali SK, Svensson LG, Tuzcu EM, Xu K, Minha S, Alu MC, Szeto WY, Thourani VH, Makkar R, Kapadia S, Satler LF, Webb JG, Leon MB, Pichard AD. Outcomes of patients with chronic lung disease and severe aortic stenosis treated with transcatheter versus surgical aortic valve replacement or standard therapy: insights from the PARTNER trial (placement of AoRTic TraNscathetER Valve). J Am Coll Cardiol. 2014 Jan 28;63(3):269-79. doi: 10.1016/j.jacc.2013.09.024. 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Determinants and outcomes of acute transcatheter valve-in-valve therapy or embolization: a study of multiple valve implants in the U.S. PARTNER trial (Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve). J Am Coll Cardiol. 2013 Jul 30;62(5):418-30. doi: 10.1016/j.jacc.2013.04.037. Epub 2013 May 15.'}, {'pmid': '23661722', 'type': 'DERIVED', 'citation': 'Herrmann HC, Pibarot P, Hueter I, Gertz ZM, Stewart WJ, Kapadia S, Tuzcu EM, Babaliaros V, Thourani V, Szeto WY, Bavaria JE, Kodali S, Hahn RT, Williams M, Miller DC, Douglas PS, Leon MB. Predictors of mortality and outcomes of therapy in low-flow severe aortic stenosis: a Placement of Aortic Transcatheter Valves (PARTNER) trial analysis. Circulation. 2013 Jun 11;127(23):2316-26. doi: 10.1161/CIRCULATIONAHA.112.001290. 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Cost-effectiveness of transcatheter aortic valve replacement compared with surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results of the PARTNER (Placement of Aortic Transcatheter Valves) trial (Cohort A). J Am Coll Cardiol. 2012 Dec 25;60(25):2683-92. doi: 10.1016/j.jacc.2012.09.018. Epub 2012 Nov 1.'}, {'pmid': '22995885', 'type': 'DERIVED', 'citation': 'Green P, Woglom AE, Genereux P, Daneault B, Paradis JM, Schnell S, Hawkey M, Maurer MS, Kirtane AJ, Kodali S, Moses JW, Leon MB, Smith CR, Williams M. The impact of frailty status on survival after transcatheter aortic valve replacement in older adults with severe aortic stenosis: a single-center experience. JACC Cardiovasc Interv. 2012 Sep;5(9):974-81. doi: 10.1016/j.jcin.2012.06.011.'}, {'pmid': '22818074', 'type': 'DERIVED', 'citation': 'Reynolds MR, Magnuson EA, Wang K, Thourani VH, Williams M, Zajarias A, Rihal CS, Brown DL, Smith CR, Leon MB, Cohen DJ; PARTNER Trial Investigators. Health-related quality of life after transcatheter or surgical aortic valve replacement in high-risk patients with severe aortic stenosis: results from the PARTNER (Placement of AoRTic TraNscathetER Valve) Trial (Cohort A). J Am Coll Cardiol. 2012 Aug 7;60(6):548-58. doi: 10.1016/j.jacc.2012.03.075. Epub 2012 Jul 18.'}, {'pmid': '22443479', 'type': 'DERIVED', 'citation': 'Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012 May 3;366(18):1686-95. doi: 10.1056/NEJMoa1200384. Epub 2012 Mar 26.'}, {'pmid': '22443478', 'type': 'DERIVED', 'citation': 'Makkar RR, Fontana GP, Jilaihawi H, Kapadia S, Pichard AD, Douglas PS, Thourani VH, Babaliaros VC, Webb JG, Herrmann HC, Bavaria JE, Kodali S, Brown DL, Bowers B, Dewey TM, Svensson LG, Tuzcu M, Moses JW, Williams MR, Siegel RJ, Akin JJ, Anderson WN, Pocock S, Smith CR, Leon MB; PARTNER Trial Investigators. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012 May 3;366(18):1696-704. doi: 10.1056/NEJMoa1202277. Epub 2012 Mar 26.'}, {'pmid': '22424519', 'type': 'DERIVED', 'citation': 'Miller DC, Blackstone EH, Mack MJ, Svensson LG, Kodali SK, Kapadia S, Rajeswaran J, Anderson WN, Moses JW, Tuzcu EM, Webb JG, Leon MB, Smith CR; PARTNER Trial Investigators and Patients; PARTNER Stroke Substudy Writing Group and Executive Committee. Transcatheter (TAVR) versus surgical (AVR) aortic valve replacement: occurrence, hazard, risk factors, and consequences of neurologic events in the PARTNER trial. J Thorac Cardiovasc Surg. 2012 Apr;143(4):832-843.e13. doi: 10.1016/j.jtcvs.2012.01.055.'}, {'pmid': '22308299', 'type': 'DERIVED', 'citation': "Reynolds MR, Magnuson EA, Wang K, Lei Y, Vilain K, Walczak J, Kodali SK, Lasala JM, O'Neill WW, Davidson CJ, Smith CR, Leon MB, Cohen DJ; PARTNER Investigators. Cost-effectiveness of transcatheter aortic valve replacement compared with standard care among inoperable patients with severe aortic stenosis: results from the placement of aortic transcatheter valves (PARTNER) trial (Cohort B). Circulation. 2012 Mar 6;125(9):1102-9. doi: 10.1161/CIRCULATIONAHA.111.054072. Epub 2012 Feb 3."}, {'pmid': '21969017', 'type': 'DERIVED', 'citation': 'Reynolds MR, Magnuson EA, Lei Y, Leon MB, Smith CR, Svensson LG, Webb JG, Babaliaros VC, Bowers BS, Fearon WF, Herrmann HC, Kapadia S, Kodali SK, Makkar RR, Pichard AD, Cohen DJ; Placement of Aortic Transcatheter Valves (PARTNER) Investigators. Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis. Circulation. 2011 Nov 1;124(18):1964-72. doi: 10.1161/CIRCULATIONAHA.111.040022. Epub 2011 Oct 3.'}, {'pmid': '21639811', 'type': 'DERIVED', 'citation': 'Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.'}, {'pmid': '20961243', 'type': 'DERIVED', 'citation': 'Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.', 'detailedDescription': 'Subjects will undergo a physical exam and screening tests will be performed to determine if they are either A) a patient with a high surgical risk or B) not a candidate for surgery. They will then be randomized (like the flip of a coin) to have the investigational device implanted or to receive the current surgical or medical management available.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria Cohort A\n\n1. Patients must have co-morbidities such that the surgeon and cardiologist Co-PIs concur that the predicted risk of operative mortality is ≥15% and/or a minimum STS score of 10\n2. Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient \\>40 mmHg or jet velocity greater than 4.0 m/s or an initial aortic valve area of \\< 0.8 cm2\n3. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater\n4. The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site\n5. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits\n\n Cohort B All candidates for Cohort B of this study must meet #2, 3, 4, 5 of the above criteria and\n6. The subject, after formal consults by a cardiologist and two cardiovascular surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. Specifically, the probability of death or serious, irreversible morbidity should exceed 50%.\n\nExclusion Criteria\n\n1. Evidence of an acute myocardial infarction ≤ 1month before the intended treatment.\n2. Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified\n3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \\>3+).\n4. Any therapeutic invasive cardiac procedure performed within 30 days of the index procedure, (or 6 months if the procedure was a drug eluting coronary stent implantation).\n5. Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency."}, 'identificationModule': {'nctId': 'NCT00530894', 'acronym': 'PARTNER', 'briefTitle': 'THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edwards Lifesciences'}, 'officialTitle': 'THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve', 'orgStudyIdInfo': {'id': '2006-06-US'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Cohort A: Sapien Valve', 'interventionNames': ['Device: Edwards SAPIEN Transcatheter Heart Valve']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Cohort A: other surgical valve', 'interventionNames': ['Device: Surgical Valve Replacement']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Cohort B: Sapien Valve', 'interventionNames': ['Device: Edwards SAPIEN Transcatheter Heart Valve']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'Cohort B: Medical therapy', 'interventionNames': ['Other: medical management and/or balloon aortic valvuloplasty']}], 'interventions': [{'name': 'Edwards SAPIEN Transcatheter Heart Valve', 'type': 'DEVICE', 'armGroupLabels': ['1', '3']}, {'name': 'Surgical Valve Replacement', 'type': 'DEVICE', 'armGroupLabels': ['2']}, {'name': 'medical management and/or balloon aortic valvuloplasty', 'type': 'OTHER', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Memorial Hospital/Scripps Green Hospital', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University HealthSystem', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Clinic', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Mass General', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic-Saint Marys Hospital', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Luke's Hospital of Kansas City", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Barnes-Jewish/Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian Hospital - Cornell', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Medical City Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84157', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Medical Center', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "Vancouver St. Paul's", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'country': 'Canada', 'facility': 'Laval Hospital', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '04289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Heart Center Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Martin B Leon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York-Presbyterian Hospital/Columbia University Medical Center'}, {'name': 'Craig Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York-Presbyterian Hospital/Columbia University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}