MedTrace Logo

The Effect of Posterior Annulus Elevation Technique in Reducing Residual Regurgitation During Mitral Valve Repair in Children

NCT04518709 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2020-08-19

No results posted yet for this study

Summary

The main problem in mitral valve repair surgery in children is the high number of postoperative residual lesions (49% of the total cases). Residual lesions after mitral valve repair are associated with morbidity and complications in the form of hemolysis and could affect the postoperative reverse remodeling process. Surgery techniques for mitral valve repair in children have fewer choices than adult patients because of the smaller and thinner valve structure. Besides, the weakness of the mitral valve repair technique that often occurs in large left ventricles with severe mitral regurgitation, after repairing with ring annuloplasty, there is usually a mild residual regurgitation due to posterior mitral leaflet that tends to become restrictive due to being attracted by the left ventricular wall that remains big. No technique has been found to overcome the problem of mitral regurgitation residuals that occur postoperatively. Therefore, by analyzing postoperative mitral valve structural abnormalities with conventional techniques, an additional posterior mitral valve elevation technique was designed to increase the area of coaptation between two leaves of the mitral valve so that the incidence of postoperative regurgitation lesions can be reduced.

Conditions

  • Mitral Valve Insufficiency

Interventions

PROCEDURE

Posterior Mitral Annulus Elevation Technique

Posterior mitral annulus elevation technique is performed using a large pledget and non-absorbable braided suture starting from the subvalvular section of the posterior mitral valve sutured to the ring annuloplasty (if in the process of repairing the mitral valve, ring implantation is performed; if without the use of ring annuloplasty, the suture is placed in the left atrial wall / supravalvular of PML), so that the posterior annulus is slightly attracted upward toward the cranial and the PML moves toward the center.

PROCEDURE

Conventional Mitral Valve Repair

Conventional mitral valve repair in the pediatric patient using annuloplasty, leaflet resection and plication, sliding-plasty of chordae technique

Sponsors & Collaborators

  • National Cardiovascular Center Harapan Kita Hospital Indonesia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-17
Primary Completion
2022-08-17
Completion
2022-08-17

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04518709 on ClinicalTrials.gov