Completed

NCT Number: NCT06778369

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

Completed

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Key information

Conditions

Mitral Valve Posterior Leaflet Prolapse

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

cardiothorathic surgery department -faculty of medecine-zagazig univeristy-Egypt

Zagazig, Sharqia Province, 44519, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

traingular exclusion technique in mitral valve repair

Procedure

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.

Primary outcomes

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
- 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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2023
First posted: Jan 16, 2025
Registry last updated: Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.