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

NCT04518709 | Unknown

• 1 other identifier: NationalCCHK
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Posterior Annulus Elevation Technique; Pediatric Mitral Valve Insufficiency

Outcome Measures

Primary Outcomes (5)

• Residual mitral valve regurgitation

  Residual mitral valve regurgitation is measured using transesophageal echocardiography and transthoracic echocardiography

  5 days after surgery

• Mitral valve coaptation area

  Mitral valve coaptation area is measured using transesophageal echocardiography and transthoracic echocardiography

  Intraoperative

• Change of Haptoglobin at 3 months after surgery

  Serum haptoglobin level that indicated the presence of intravascular hemolysis is measured after the surgery

  Preoperative (baseline), 5 days, 2 weeks and 3 months after surgery

• Change of Lactate dehydrogenase at 3 months after surgery

  Lactate dehydrogenase level that indicated the presence of intravascular hemolysis is measured after the surgery

  Preoperative (baseline), 5 days, 2 weeks and 3 months after surgery

• Change of NT-proBNP at 3 months after surgery

  NTproBNP is a marker of acute heart failure and indicates the process of heart remodeling.

  Preoperative (baseline), 5 days, 2 weeks and 3 months after surgery

Study Arms (2)

Posterior Annulus Elevation Technique Group

EXPERIMENTAL

In patients who were determined in the treatment group, after the conventional procedure for mitral valve repair was completed, a posterior mitral valve elevation technique will be performed.

Procedure: Posterior Mitral Annulus Elevation Technique

Without Posterior Annulus Elevation Technique Group

PLACEBO COMPARATOR

No additional procedure will be done after conventional mitral valve repair

Procedure: Conventional Mitral Valve Repair

Interventions

Posterior Mitral Annulus Elevation Technique PROCEDURE

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.

Posterior Annulus Elevation Technique Group

Conventional Mitral Valve Repair PROCEDURE

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

Without Posterior Annulus Elevation Technique Group

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with mitral regurgitation heart disease.
• Patients with an age range of 1 day - 18 years
• Patients with mitral regurgitation heart disease with atrial septal defects
• Mitral valve repair surgery performed by single surgeon (Budi Rahmat, MD)

You may not qualify if:

• Patients refuse to participate in the study.
• Having additional cardiac abnormalities other than atrial septal defects that change the surgery plan.
• Reoperation mitral valve surgery.
• History of abnormalities in the central nervous system / preoperative stroke.
• Patients with severe pulmonary hypertension
• Patients with small left ventricles (LV smallish)
• History of pulmonary resuscitation (CPR) before surgery.
• Dropout Criteria
• The patient fails to complete the entire examination procedure.
• Mitral regurgitation patients who are decided to do mitral valve replacement intra-operatively.
• Using extracorporeal life support (ECMO) device after surgery.
• History of intra-operative CPR.

Sponsors & Collaborators

• National Cardiovascular Center Harapan Kita Hospital Indonesia: lead

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Budi Rahmat, MD

CONTACT

+628128800076; budirahmat@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Pediatric & Congenital Heart Surgery Division

Study Record Dates

• First Submitted: August 2, 2020
• First Posted: August 19, 2020
• Study Start: August 17, 2020
• Primary Completion: August 17, 2022
• Study Completion: August 17, 2022
• Last Updated: August 19, 2020

Record last verified: 2020-08