Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-01-03 @ 9:40 PM
Study NCT ID:
NCT00475267
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2007-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aortic Valve Replacement With Trifecta(TM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001022', 'term': 'Aortic Valve Insufficiency'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 203}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2007-05-16', 'studyFirstSubmitQcDate': '2007-05-16', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterize patient NYHA functional classification status.', 'timeFrame': 'At required follow-up intervals'}, {'measure': 'Characterize the hemodynamic performance of the valve.', 'timeFrame': 'At required follow-up intervals'}, {'measure': 'Establish adverse event rates.', 'timeFrame': 'Ongoing'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['aortic valve', 'heart valve', 'tissue valve', 'bioprosthesis', 'valve disorder', 'valve disease', 'cardiac surgery', 'aortic valve stenosis', 'aortic valve regurgitation'], 'conditions': ['Aortic Valve Insufficiency', 'Regurgitation, Aortic Valve', 'Aortic Valve Incompetence', 'Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to confirm the clinical safety and effectiveness of the Trifecta valve.', 'detailedDescription': 'The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study designed to evaluate the safety and effectiveness of the Trifecta valve.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Requires aortic valve replacement (heart surgery such as bypass is allowed at the same time).\n* Legal age.\n* Signed informed consent prior to surgery.\n* Willing to complete all follow-up requirements.\n\nExclusion Criteria:\n\n* Pregnant or nursing women.\n* Have already had a valve replaced other than the aortic valve.\n* Needs another valve replaced.\n* Cannot return for required follow-up visits.\n* Have active endocarditis.\n* Acute preoperative neurological event (such as a stroke).\n* Renal dialysis.\n* History of substance abuse within one year, or a prison inmate.\n* Participating in another study.\n* Life expectancy less than two years.'}, 'identificationModule': {'nctId': 'NCT00475267', 'briefTitle': 'Aortic Valve Replacement With Trifecta(TM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'An Observational, Prospective Evaluation of the Trifecta Valve', 'orgStudyIdInfo': {'id': 'CS0601'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Trifecta aortic heart valve', 'type': 'DEVICE', 'description': 'Intended as a replacement for a diseased, damaged, or malfunctioning aortic heart valve.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "University of British Columbia, St. Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'B3H 3A7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'QEII Health Sciences Center', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network - Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'GN 4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hôpital Laval', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Hartzell Schaff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}