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

January 11, 2025 updated by: Sameh Elsayed Saeed Elsayed, Zagazig University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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
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

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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