Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT01537458
Status:
COMPLETED
Last Update Posted:
2023-01-27
First Post:
2012-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Outcome After Isolated Tricuspid Valve Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014262', 'term': 'Tricuspid Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2013-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-26', 'studyFirstSubmitDate': '2012-02-13', 'studyFirstSubmitQcDate': '2012-02-22', 'lastUpdatePostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': '10 year'}, {'measure': 'Redo surgery', 'timeFrame': '10 year'}], 'secondaryOutcomes': [{'measure': 'functional capacity assessed by CPET', 'timeFrame': '10 year'}, {'measure': 'Atrial fibrillation', 'timeFrame': '10 year'}, {'measure': 'Hospitalisation', 'timeFrame': '10 year', 'description': 'hospitalisation for cardiovascular reasons'}, {'measure': 'Functional capacity assessed by NYHA functional class', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Tricuspid Valve Insufficiency']}, 'descriptionModule': {'briefSummary': 'Tricuspid valve insufficiency (TI) is often noted on echocardiography. Although severe TI is known to cause significant morbidity and mortality, no good guidelines are available to guide intervention. Literature is mostly confined to tricuspid valve repair concomitant with mitral valve repair. Treatment options for isolated repair have not been investigated thoroughly.\n\nThe investigators want to evaluate retrospectively the outcome of isolated tricuspid valve repair, performed in our center. By doing this, the investigators want to evaluate predictors of outcome after repair.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing isolated tricuspid valve repair', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* tricuspid valve insufficiency\n\nExclusion Criteria:\n\n* younger than 18 years\n* associated valvular surgery'}, 'identificationModule': {'nctId': 'NCT01537458', 'briefTitle': 'Long-term Outcome After Isolated Tricuspid Valve Repair', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'orgStudyIdInfo': {'id': 'Is_TVR_1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Isolated TI repair', 'description': 'Patients that underwent isolated tricuspid valve repair', 'interventionNames': ['Procedure: follow-up of isolated tricuspid valve repair']}], 'interventions': [{'name': 'follow-up of isolated tricuspid valve repair', 'type': 'PROCEDURE', 'description': 'follow-up of patients that underwent TV repair in the past.', 'armGroupLabels': ['Isolated TI repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'country': 'Belgium', 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Science, Technology and Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}