Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-25 @ 8:32 PM
Study NCT ID:
NCT05774769
Status:
COMPLETED
Last Update Posted:
2023-03-20
First Post:
2023-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Commissural Closure to Treat Severe Mitral Regurgitation: Standing the Test of Time.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-16', 'studyFirstSubmitDate': '2023-01-30', 'studyFirstSubmitQcDate': '2023-03-16', 'lastUpdatePostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Through study completion, an average of 14,5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Degenerative Mitral Valve Disease']}, 'descriptionModule': {'briefSummary': 'Mitral regurgitation (MR) for degenerative disease is nowadays routinely treated with valve repair with excellent short and long term results in experienced centers. However, repair durability can varies according to the characteristics of the initial lesion, and better long term durability in isolated lesions of the posterior leaflets compared to anterior or bi-leaflets prolapse has been shown. A commissural MR can be caused by lesions of the anterior, posterior or both leaflets and several surgical techniques have been proposed to treat these lesions. However, long term outcomes of mitral valve repair (MVr) for isolated commissural flail or prolapse remain poor defined. In San Raffaele Hospital cardiac surgery, commissural lesions are usually treated with a functional approach, by means of edge-to-edge approximation of the anterior and posterior leaflet at the commissural area (commissural closure). The investigators previously reported the short and mid-term outcomes of this technique with satisfactory results. With this study the investigators aim to analyze the very long term clinical and echocardiographic results of isolated commissural lesions treated with commissural closure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a degenerative mitral valve disease in whom regurgitation occurred in commissural position, hence were treated with a commisural edge to edge surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients;\n* Patients underwent mitral valve repair for flail or isolated commissural prolapse, of posterior, anterior or bileaflet origin;\n* Patients operated on with median sternotomy or left minithoracotomy;\n* Patients in whom the commissural MR has been treated with commissural closure and annuloplasty;\n* Patients operated on at the Cardiac Surgery department of San Raffaele Hospital from January 1997 to December 2007.\n\nExclusion Criteria:\n\n* Patients underwent a mitral valve replacement'}, 'identificationModule': {'nctId': 'NCT05774769', 'briefTitle': 'Commissural Closure to Treat Severe Mitral Regurgitation: Standing the Test of Time.', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale San Raffaele'}, 'officialTitle': 'Commissural Closure to Treat Severe Mitral Regurgitation: Standing the Test of Time.', 'orgStudyIdInfo': {'id': 'COSMIR'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Commissural edge to edge mitral valve repair', 'type': 'PROCEDURE', 'description': 'Edge to edge is the suture of mitral valve leaflets tissue in the regurgitant spot. If the regurgitant jet is near a mitral commissure, it is called a commissural edge to edge.'}]}, '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'}}}}