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

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

Study Overview

• Status: Completed
• Conditions: Mitral Valve Posterior Leaflet Prolapse
• Intervention / Treatment: Procedure: traingular exclusion technique in mitral valve repair

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Sharkia
    • Zagazig, El Sharkia, Egypt, 44519
      • cardiothorathic surgery department -faculty of medecine-zagazig univeristy-Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: traingular exclusion technique; Triangular exclusion technique in isolated posterior mitral valve leaflet prolapse for mitral valve repair

Procedure: traingular exclusion technique in mitral valve repair; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: sameh saeed, lecturer, cardiothoracic surgery department-faculty of medecine-Zagazig univeristy-Egypt

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Actual): April 20, 2022
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: December 27, 2024
• First Submitted That Met QC Criteria: January 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 11, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Mitral valve repair;Triangular Exclusion Technique
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse
• Other Study ID Numbers: ZU-IRB # 11120-20-9-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No