Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-02-01 @ 7:35 PM
Study NCT ID:
NCT02687035
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2016-02-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PARTNER II Trial: S3iCAP
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065467', 'term': 'Transcatheter Aortic Valve Replacement'}], 'ancestors': [{'id': 'D019918', 'term': 'Heart Valve Prosthesis Implantation'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'THV_CT.gov@edwards.com', 'phone': '949-250-2500', 'title': 'Edwards THV Clinical Affairs', 'organization': 'Edwards Lifesciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All events are reported at 1 year.', 'description': 'This trial used the TVT Registry Data Collection Form and database. On the TVT Registry Data Collection Form, clinical sites do not report the seriousness of adverse events, therefore seriousness was determined by the sponsor based on the standardized definition of a serious adverse event.', 'eventGroups': [{'id': 'EG000', 'title': 'SAPIEN 3', 'description': 'Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.', 'otherNumAtRisk': 1814, 'deathsNumAtRisk': 1814, 'otherNumAffected': 0, 'seriousNumAtRisk': 1814, 'deathsNumAffected': 87, 'seriousNumAffected': 818}], 'seriousEvents': [{'term': 'Conduction/native pacer disturbance requiring pacemaker', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 220, 'numAffected': 219}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-valve Related Readmission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 458, 'numAffected': 354}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unplanned Vascular Surgery or Intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 54, 'numAffected': 53}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischemic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 50, 'numAffected': 49}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Perforation with or w/o Tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Major Vascular Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unplanned Other Cardiac Surgery or Intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 31, 'numAffected': 29}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Percutaneous Coronary Intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conduction/native pacer disturbance requiring Implantable Cardioverter Defibrillator', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Major Bleeding Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 33, 'numAffected': 32}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retroperitoneal Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aortic Dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Valve Related Readmission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary Compression or Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Life Threatening Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Undetermined Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New Requirement for Dialysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhagic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Annular Dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Device Embolization Left Ventricle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aortic Valve Re-intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1814, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1814', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAPIEN 3', 'description': 'Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Number of deaths', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1814', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAPIEN 3', 'description': 'Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Number of deaths', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1814', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAPIEN 3', 'description': 'Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Number of participants with stroke', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1814', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAPIEN 3', 'description': 'Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Number of participants with stroke', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Aortic Valve Reintervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1814', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAPIEN 3', 'description': 'Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Number of participants with aortic valve reintervention', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Aortic Valve Reintervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1814', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAPIEN 3', 'description': 'Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Number of participants with aortic valve reintervention', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Annular Dissection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1814', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAPIEN 3', 'description': 'Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Number of participants with annular dissection', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aortic Dissection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1814', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAPIEN 3', 'description': 'Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Number of participants with aortic dissection', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Major Access Vascular Site Complication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1814', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAPIEN 3', 'description': 'Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Number of participants with major vascular complications', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Unplanned Vascular Surgery or Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1814', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAPIEN 3', 'description': 'Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Number of participants with unplanned vascular surgery or intervention', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Retroperitoneal Bleeds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1814', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAPIEN 3', 'description': 'Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Number of participants with retroperitoneal bleed', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gastrointestinal Bleed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1814', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAPIEN 3', 'description': 'Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Number of participants with gastrointestinal bleeding', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Genitourinary Bleed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1814', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAPIEN 3', 'description': 'Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Number of participants with genitourinary bleeding', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bleeding at Access Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1814', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SAPIEN 3', 'description': 'Intermediate risk patients receiving SAPIEN S3 valve with Commander or Certitude delivery system.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Number of participants with bleeding at the access site', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SAPIEN 3', 'description': 'Patients at intermediate surgical risk receiving the SAPIEN S3 valve with Commander or Certitude delivery system.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1822'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1638'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '87'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Missed Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '87'}]}, {'type': 'Did not receive Study Device', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'Recruitment took place from January 2015 to August 2016. Subjects in this trial were entered into the TVT Registry. Of the 1822 subjects enrolled in the trial, 1814 subjects received the study device.', 'preAssignmentDetails': 'Participants that did not receive an Edwards device were not followed in the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1814', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SAPIEN 3', 'description': 'Intermediate risk patients receiving the SAPIEN S3 valve with Commander or Certitude delivery system.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '80.7', 'spread': '6.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '786', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1028', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '67', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1705', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Society of Thoracic Surgeons (STS) Score', 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '1.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Society of Thoracic Surgeons (STS) Score measures patient risk of mortality or morbidity at the time of cardiovascular surgery on a scale that ranges from 0% to 100%, with higher numbers indicating greater risk of operative mortality.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'New York Heart Association (NYHA) Class', 'classes': [{'categories': [{'title': 'NYHA I', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'NYHA II', 'measurements': [{'value': '682', 'groupId': 'BG000'}]}, {'title': 'NYHA III', 'measurements': [{'value': '1041', 'groupId': 'BG000'}]}, {'title': 'NYHA IV', 'measurements': [{'value': '90', 'groupId': 'BG000'}]}, {'title': 'Not Assessed', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'New York Heart Association (NYHA) functional classification of heart failure is based on how much a patient is limited during physical activity. The rating ranges from I-IV. I = no limitations of physical activity; II = slight limitations of physical activity, ordinary physical activity results in fatigue, palpitation, shortness of breath; III = marked limitations of physical activity, less than ordinary activity causes fatigue, palpitation, or shortness of breath; IV = unable to carry on any physical activity without discomfort, symptoms of heart failure at rest.', 'unitOfMeasure': 'Participants'}], 'populationDescription': '1814 subjects received the SAPIEN 3 valve'}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2015-09-01', 'size': 676420, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-11-17T18:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1822}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-12', 'studyFirstSubmitDate': '2016-02-01', 'resultsFirstSubmitDate': '2020-12-22', 'studyFirstSubmitQcDate': '2016-02-16', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-12', 'studyFirstPostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death', 'timeFrame': '30 days', 'description': 'Number of deaths'}, {'measure': 'Death', 'timeFrame': '1 year', 'description': 'Number of deaths'}, {'measure': 'Stroke', 'timeFrame': '30 days', 'description': 'Number of participants with stroke'}, {'measure': 'Stroke', 'timeFrame': '1 year', 'description': 'Number of participants with stroke'}, {'measure': 'Aortic Valve Reintervention', 'timeFrame': '30 days', 'description': 'Number of participants with aortic valve reintervention'}, {'measure': 'Aortic Valve Reintervention', 'timeFrame': '1 year', 'description': 'Number of participants with aortic valve reintervention'}], 'secondaryOutcomes': [{'measure': 'Annular Dissection', 'timeFrame': '30 days', 'description': 'Number of participants with annular dissection'}, {'measure': 'Aortic Dissection', 'timeFrame': '30 days', 'description': 'Number of participants with aortic dissection'}, {'measure': 'Major Access Vascular Site Complication', 'timeFrame': '30 days', 'description': 'Number of participants with major vascular complications'}, {'measure': 'Unplanned Vascular Surgery or Intervention', 'timeFrame': '30 days', 'description': 'Number of participants with unplanned vascular surgery or intervention'}, {'measure': 'Retroperitoneal Bleeds', 'timeFrame': '30 days', 'description': 'Number of participants with retroperitoneal bleed'}, {'measure': 'Gastrointestinal Bleed', 'timeFrame': '30 days', 'description': 'Number of participants with gastrointestinal bleeding'}, {'measure': 'Genitourinary Bleed', 'timeFrame': '30 days', 'description': 'Number of participants with genitourinary bleeding'}, {'measure': 'Bleeding at Access Site', 'timeFrame': '30 days', 'description': 'Number of participants with bleeding at the access site'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['S3iCAP', 'SAPIEN 3', 'Transfemoral', 'Commander', 'Certitude', 'TAVR', 'TAVI', 'Aortic stenosis', 'THV', 'Transcatheter Heart Valve', 'TVT', 'TVTR'], 'conditions': ['Aortic Stenosis']}, 'referencesModule': {'references': [{'pmid': '34387097', 'type': 'DERIVED', 'citation': 'Abbas AE, Ternacle J, Pibarot P, Xu K, Alu M, Rogers E, Hahn RT, Leon M, Thourani VH. Impact of Flow on Prosthesis-Patient Mismatch Following Transcatheter and Surgical Aortic Valve Replacement. Circ Cardiovasc Imaging. 2021 Aug;14(8):e012364. doi: 10.1161/CIRCIMAGING.120.012364. Epub 2021 Aug 13.'}]}, 'descriptionModule': {'briefSummary': 'Following completion of enrollment in the PARTNER II SAPIEN 3 intermediate risk trial, this trial provided continued access to treatment for subjects with severe aortic stenosis who were at intermediate surgical risk.', 'detailedDescription': 'This multi-center, single arm registry will provide continued access of the Edwards SAPIEN 3 Transcatheter Heart Valve and delivery systems to severe aortic stenosis patients at intermediate risk for standard aortic valve replacement. Patient data will be entered into the TVT Registry (TVTR) from screening through 1 year including the collection of 5 year follow-up through CMS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must be covered by Medicare. This will enable Edwards to link to the CMS database for long term follow-up through 5 years. No other insurance provider will be accepted.\n2. Assessment of intermediate surgical risk defined as STS 4-8% or heart team assessment of intermediate risk factors.\n3. Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient \\> 40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of \\< 0.8 cm2 or indexed EOA \\< 0.5 cm2/m2. Qualifying echo must be within 60 days of the date of the procedure.\n4. Aortic valve annulus area range (273mm2-680 mm2) per 3D imaging (echo, CT, or MRI).\n5. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.\n6. The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient.\n7. Heart team agrees (a priori) on treatment strategy for concomitant coronary disease (if present).\n8. The study patient or the study patient\'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 Institutional Review Board (IRB) of the respective clinical site.\n9. The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up.\n\nExclusion Criteria:\n\n1. Heart team assessment of inoperability (including examining cardiac surgeon).\n2. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment \\[(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)\\].\n3. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.\n4. Mixed aortic valve disease (aortic stenosis and aortic re-regurgitation with predominant aortic regurgitation \\>3+).\n5. Pre-existing mechanical or bioprosthetic valve in any position.\n6. Complex coronary artery disease:\n\n 1. Unprotected left main coronary artery\n 2. Syntax score \\> 32 (in the absence of prior revascularization)\n7. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker or ICD is not considered exclusion criteria.\n8. Any patient with a balloon valvuloplasty (BAV) \\< 30 days of the procedure (unless BAV is a bridge to procedure after a qualifying ECHO).\n9. Patients with planned concomitant surgical or transcatheter ablation for atrial fibrillation.\n10. Leukopenia (WBC \\< 3000 cell/mL), acute anemia (Hgb \\< 9 g/dL), thrombocytopenia (Plt \\< 50,000 cell/mL).\n11. Hypertrophic cardiomyopathy with or without obstruction (HOCM).\n12. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of screening evaluation.\n13. Need for emergency surgery for any reason.\n14. Severe ventricular dysfunction with LVEF \\< 20%.\n15. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.\n16. Active upper GI bleeding within 3 months (90 days) prior to procedure.\n17. A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.\n18. Native aortic annulus size \\< 16 mm or \\> 28mm as measured by echocardiogram.\n19. Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 6 months (180 days) of the procedure.\n20. Renal insufficiency (creatinine \\> 3.0 mg/dL) and/or renal replacement therapy at the time of screening.\n21. Estimated life expectancy \\< 24 months (730 days) due to carcinomas, chronic liver disease, chronic renal dis-ease or chronic end stage pulmonary disease.\n22. Expectation that patient will not improve despite treatment of aortic stenosis.\n23. Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma \\[especially if thick (\\> 5 mm), protruding or ulcerated\\] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta. (Transfemoral)\n24. Iliofemoral vessel characteristics that would preclude safe placement of 14F or 16F introducer sheath such as severe obstructive calcification, severe tortuosity or min-imum average vessel size less than 5.5 mm. (Transfem-oral).\n25. Currently participating in an investigational drug or an-other device study. Note: Trials requiring extended fol-low-up for products that were investigational, but have since become commercially available, are not considered investigational trials.\n26. Active bacterial endocarditis within 6 months (180 days) of procedure.\n27. Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis.\n28. Inability to tolerate anticoagulation/antiplatelet therapy.\n29. For transfemoral approach only: Femoro-iliac vessels \\< 5.5 mm for the 23 mm and the 26 mm system and \\< 6.0 mm for the 29 mm system.'}, 'identificationModule': {'nctId': 'NCT02687035', 'acronym': 'PII S3i CAP', 'briefTitle': 'PARTNER II Trial: S3iCAP', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edwards Lifesciences'}, 'officialTitle': 'The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves: Continued Access Program for SAPIEN 3 Intermediate Risk (S3iCAP)', 'orgStudyIdInfo': {'id': '2010-12 S3iCAP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAVR', 'description': 'Intermediate risk patients receiving transcatheter aortic valve replacement (TAVR)', 'interventionNames': ['Device: SAPIEN S3 valve']}], 'interventions': [{'name': 'SAPIEN S3 valve', 'type': 'DEVICE', 'otherNames': ['TAVR', 'TAVI', 'Transcatheter aortic valve replacement', 'SAPIEN'], 'description': 'Transcatheter aortic valve replacement', 'armGroupLabels': ['TAVR']}]}, 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