Triangular Exclusion Technique in Isolated Posterior Mitral Valve Leaflet Prolapse for Mitral Valve Repair

Not Applicable

Completed

• Conditions: Mitral Valve Posterior Leaflet Prolapse

• Registration Number: NCT06778369
• Lead Sponsor: Zagazig University

Brief Summary

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

The main questions aims to answer is:

Does 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

Detailed Description

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

Study Timeline

• Study Start: 2020-06-15
• Primary Completion: 2022-04-20
• Study Completion: 2023-06-15
• Study First Submitted: 2024-12-27
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-11
• Last Update Submitted: 2025-01-11
• Study First Posted: 2025-01-16
• Last Update Posted: 2025-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• varying degrees of degenerative MV regurgitation, ranging from moderate to severe or severe caused by isolated prolapse of the posterior MV leaflet
• concomitant tricuspid annuloplasty

Exclusion Criteria

• with Mitral Valve stenosis or any other manifestation of mitral regurgitation pathology.
• individuals requiring surgical intervention for the aortic or pulmonary valves

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
degree of postoperative mitral valve regurgitation following Triangular Exclusion Technique	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	Suggested Quality Metrics for Interventions for Mitral Regurgitation; 1. Procedural success Absence of moderate or worse residual mitral regurgitation (on TTE within 30 days) Absence of stroke or mortality; 2. Procedural effectiveness (1 year) Alive Freedom from moderate or worse mitral regurgitation Freedom from cardiovascular reintervention Freedom from NYHA functional class III-IV symptoms; 3. 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

Trial Locations

Locations (1)

cardiothorathic surgery department -faculty of medecine-zagazig univeristy-Egypt; 🇪🇬 Zagazig, El Sharkia, Egypt