Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT04555967
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-17
First Post:
2020-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SAPIEN 3 Ultra System PMCF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2020-09-01', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device success per VARC-3, defined as meeting all of the following:', 'timeFrame': '30 days', 'description': '* Technical success\n* Freedom from mortality\n* Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication\n* Intended performance of the valve (mean gradient \\< 20 mmHg, peak velocity \\< 3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation)'}], 'secondaryOutcomes': [{'measure': 'Death', 'timeFrame': '1 year'}, {'measure': 'Stroke', 'timeFrame': '30 days and 1 year'}, {'measure': 'Major vascular complications', 'timeFrame': '30 days'}, {'measure': 'Life threatening bleeding', 'timeFrame': '30 days'}, {'measure': 'New conduction defects requiring permanent pacemaker', 'timeFrame': '30 days'}, {'measure': 'Acute kidney injury stage 2-3', 'timeFrame': '7 days'}, {'measure': 'New onset atrial fibrillation', 'timeFrame': '30 days'}, {'measure': 'Rehospitalization (valve-related or due to worsening heart failure)', 'timeFrame': '1 year'}, {'measure': 'Paravalvular leak', 'timeFrame': '30 days and 1 year'}, {'measure': 'Mean aortic valve gradient', 'timeFrame': '30 days and 1 year'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Transcatheter Aortic Valve Implantation', 'Transcatheter Aortic Valve Replacement', 'SAPIEN 3 Ultra'], 'conditions': ['Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.', 'detailedDescription': 'To monitor and review device performance and outcomes of the SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with symptomatic, severe, calcific aortic stenosis treated per the indications for use in the Instructions for Use', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Subject meets the criteria per the Indication and Contraindications according to the current IFUs.\n\n * Indication for Use: The Edwards SAPIEN 3 Ultra THV, the Edwards SAPIEN 3 THV, and the associated delivery systems are indicated for use in patients with severe, symptomatic, calcific aortic valve stenosis who are judged by a Heart Team, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 3% at 30 days, based on the STS risk score and other clinical comorbidities unmeasured by the STS risk calculator).\n * Contraindications: Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis; Inability to tolerate anticoagulation/antiplatelet therapy.\n2. Subject has provided written informed consent to comply with all study procedures and follow-up visits'}, 'identificationModule': {'nctId': 'NCT04555967', 'briefTitle': 'SAPIEN 3 Ultra System PMCF', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edwards Lifesciences'}, 'officialTitle': 'SAPIEN 3 Ultra System Post-Market Clinical Follow-up Study', 'orgStudyIdInfo': {'id': '2018-09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transcatheter aortic valve implantation', 'interventionNames': ['Device: SAPIEN 3 Ultra System']}], 'interventions': [{'name': 'SAPIEN 3 Ultra System', 'type': 'DEVICE', 'description': 'Transcatheter aortic valve implantation', 'armGroupLabels': ['Transcatheter aortic valve implantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medizinische Universitaet Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St. Paul's Hospital Vancouver", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital, Skejby', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '00100', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '20251', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitares Herzzentrum Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '54100', 'city': 'Massa', 'country': 'Italy', 'facility': 'Ospedale G. Pasquinucci', 'geoPoint': {'lat': 44.03541, 'lon': 10.13927}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': 'BT12 6BA', 'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'Royal Victoria Hospital Belfast', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital London", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}