Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-02-22 @ 6:47 PM
Study NCT ID:
NCT01519050
Status:
UNKNOWN
Last Update Posted:
2012-01-26
First Post:
2012-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors of Postoperative Left Ventricular Function in Patients Undergoing Mitral Valve Repair for Severe Degenerative Mitral Regurgitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D058386', 'term': 'Mitral Valve Annuloplasty'}], 'ancestors': [{'id': 'D058385', 'term': 'Cardiac Valve Annuloplasty'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-01-25', 'studyFirstSubmitDate': '2012-01-23', 'studyFirstSubmitQcDate': '2012-01-25', 'lastUpdatePostDateStruct': {'date': '2012-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Severe Degenerative Mitral Regurgitation']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate whether a predictive score (combination of several validated predictors) better predicts postoperative left ventricular function than any single predictor in patients undergoing mitral valve repair for degenerative mitral regurgitation.\n\nA single center, prospective cohort study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '100 patients with mitral valve proplapse ondergoing mitral valve repair for severe mitral regurgitation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age 18- 85 years\n* Patients with severe degenerative mitral regurgitation undergoing mitral valve repair at our institution\n\nExclusion criteria:\n\n* Functional or ischemic mitral regurgitation\n* Presence of relevant (symptomatic) Coronary Artery Disease\n* Inability of exercising on semi supine bicycle'}, 'identificationModule': {'nctId': 'NCT01519050', 'briefTitle': 'Predictors of Postoperative Left Ventricular Function in Patients Undergoing Mitral Valve Repair for Severe Degenerative Mitral Regurgitation', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'orgStudyIdInfo': {'id': 'KEK ZH 2011- 0274'}}, 'armsInterventionsModule': {'interventions': [{'name': 'mitral valve repair', 'type': 'BEHAVIORAL', 'description': 'Mitral valve repair in patients with degenerative mitral regurgitation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Division of Cardiology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Ines Bühler, Study Coordinator', 'role': 'CONTACT', 'email': 'ines.buehler@usz.ch', 'phone': '+41 (0)44 255 11 11'}, {'name': 'Patric Biaggi, MD', 'role': 'CONTACT', 'email': 'patric.biaggi@usz.ch'}], 'overallOfficials': [{'name': 'Patric Biaggi, MD, Senior physican', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Division of Cardiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}