Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 11:34 PM
Study NCT ID:
NCT05836493
Status:
COMPLETED
Last Update Posted:
2023-05-01
First Post:
2023-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Very Long-term (>15 Years) Results of 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': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-28', 'studyFirstSubmitDate': '2023-01-27', 'studyFirstSubmitQcDate': '2023-04-28', 'lastUpdatePostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'through study completion, a minimum of 15 years'}], 'secondaryOutcomes': [{'measure': 'Reintervention', 'timeFrame': 'through study completion, a minimum of 15 years'}, {'measure': 'TR recurrence', 'timeFrame': 'through study completion, a minimum of 15 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tricuspid Regurgitation']}, 'descriptionModule': {'briefSummary': 'Interest in Tricuspid valve disease grew exponentially in the last years in response to an increased awareness of the poor outcome of patients with functional Tricuspid Regurgitation (TR). Earlier reports advocated for a more conservative TR management in patients undergoing left-sided heart valve surgery but more recent guidelines advised for a more aggressive TR management, as accumulating evidence demonstrates its adverse impact on long term morbidity and mortality. Several papers have been published analyzing the results of surgical tricuspid valve repair but the length of the follow-up is usually limited to 10 to 12 years. With this study the investigators aim to analyze the very long-term results (\\>15years) of tricuspid valve repair according to the surgical method employed for valve repair (suture vs ring annuloplasty).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '\\- patients operated for non-valvular procedures (e.g. coronary artery bypass)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cardiac surgery treatment of TR, isolated or in conjunction with other procedures on the left heart\n* patients operated on between January 1998 and December 2004\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT05836493', 'briefTitle': 'Very Long-term (>15 Years) Results of Tricuspid Valve Repair.', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale San Raffaele'}, 'officialTitle': 'Very Long-term (>15 Years) Results of Tricuspid Valve Repair.', 'orgStudyIdInfo': {'id': 'VLT-TVR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ring annuloplasty', 'interventionNames': ['Procedure: Ring annuloplasty']}, {'label': 'Suture procedure', 'interventionNames': ['Procedure: Suture procedure']}], 'interventions': [{'name': 'Ring annuloplasty', 'type': 'PROCEDURE', 'description': 'A prosthetic ring is implanted to treat tricuspid regurgitation', 'armGroupLabels': ['Ring annuloplasty']}, {'name': 'Suture procedure', 'type': 'PROCEDURE', 'description': 'Suture techniques such as Kay or De Vega are used to reduce tricuspid annulus in order to treat tricuspid regurgitation', 'armGroupLabels': ['Suture procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michele De Bonis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief of Cardiac Surgery of Advanced and Research Therapies', 'investigatorFullName': 'Michele De Bonis', 'investigatorAffiliation': 'Ospedale San Raffaele'}}}}