Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT06778369
Status:
COMPLETED
Last Update Posted:
2025-01-16
First Post:
2024-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Triangular Exclusion Technique in Isolated Posterior Mitral Valve Leaflet Prolapse for Mitral Valve Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-11', 'studyFirstSubmitDate': '2024-12-27', 'studyFirstSubmitQcDate': '2025-01-11', 'lastUpdatePostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'degree of postoperative mitral valve regurgitation following Triangular Exclusion Technique', 'timeFrame': 'about 13 months From enrolment to the end of surgical procedure about one month follow up Echo done after 6 and 12 months so total time frame about 13 months duration', 'description': 'Suggested Quality Metrics for Interventions for Mitral Regurgitation\n\n1. Procedural success Absence of moderate or worse residual mitral regurgitation (on TTE within 30 days) Absence of stroke or mortality\n2. Procedural effectiveness (1 year) Alive Freedom from moderate or worse mitral regurgitation Freedom from cardiovascular reintervention Freedom from NYHA functional class III-IV symptoms\n3. Durability (5 years or later) Freedom from moderate or worse mitral regurgitation Freedom from mitral valve reintervention But our study limited to only 1 year follow up due to our academic authorities that will be added as one of the strong limitations of our study but we will mention at conclusion and recommendations to extend the sample size and follow up period of the operated patients till 5 years in the following studies that interested by the same topic'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mitral valve repair;Triangular Exclusion Technique'], 'conditions': ['Mitral Valve Posterior Leaflet Prolapse']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if surgical method done to repair one of the heart valve called mitral valve disease during open heart surgery\n\nThe main questions aims to answer is:\n\nDoes this method is safe and effective for long time and can be used in special cases of mitral valve surgery ? participants come to clinic to be checked clinically and radiologcally every month by the surgeon till 12 month', 'detailedDescription': 'the surgical method isThe prolapsed part of the posterior leaflet of the mitral valve is inverted and excluded, toward the left ventricle but not cutted echocardiography done before participants leave hospital after sugery, after 6 month and after 12 months to confirm that this method of repair is safe and effective for participants life long'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* varying degrees of degenerative MV regurgitation, ranging from moderate to severe or severe caused by isolated prolapse of the posterior MV leaflet\n* concomitant tricuspid annuloplasty\n\nExclusion Criteria:\n\n* with Mitral Valve stenosis or any other manifestation of mitral regurgitation pathology.\n* individuals requiring surgical intervention for the aortic or pulmonary valves'}, 'identificationModule': {'nctId': 'NCT06778369', 'briefTitle': 'Triangular Exclusion Technique in Isolated Posterior Mitral Valve Leaflet Prolapse for Mitral Valve Repair', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Triangular Exclusion Technique in Isolated Posterior Mitral Valve Leaflet Prolapse for Mitral Valve Repair', 'orgStudyIdInfo': {'id': 'ZU-IRB # 11120-20-9-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'traingular exclusion technique', 'description': 'Triangular exclusion technique in isolated posterior mitral valve leaflet prolapse for mitral valve repair', 'interventionNames': ['Procedure: traingular exclusion technique in mitral valve repair']}], 'interventions': [{'name': 'traingular exclusion technique in mitral valve repair', 'type': 'PROCEDURE', 'description': "The prolapsed part of the posterior leaflet is inverted and excluded, not resected toward the left ventricle, and the margins of the prolapsed part are sutured to each other's using proline 5/0, extending from the posterior leaflet edge to the posterior annulus. Then the posterior annulus is reinforced with an annuloplasty band using a treated strip of pericardium. The determination of suitable ring size is subsequently predicated upon the assessment of inter-commissural distance surface area and the anterior leaflet, utilizing sizers that are correlated with typical mitral geometry.", 'armGroupLabels': ['traingular exclusion technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44519', 'city': 'Zagazig', 'state': 'Sharqia Province', 'country': 'Egypt', 'facility': 'cardiothorathic surgery department -faculty of medecine-zagazig univeristy-Egypt', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'overallOfficials': [{'name': 'sameh saeed, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'cardiothoracic surgery department-faculty of medecine-Zagazig univeristy-Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Sameh Elsayed Saeed Elsayed', 'investigatorAffiliation': 'Zagazig University'}}}}