A Prospective Multicenter Cohort Study on Surgical Treatment Strategies for Pediatric Mitral Regurgitation

National Center for Cardiovascular Diseases

Status: Completed

Conditions: Mitral Regurgitation (MR); Pediatric Cardiac Surgery

Treatments: Procedure: conventional mitral valve repair; Procedure: standardized mitral valve repair

Study type: Observational

Funder types: Other

Identifiers

NCT07284212

2020-FW-MR

Details and patient eligibility

About

This prospective, multicenter cohort study aims to evaluate the outcomes of surgical repair for pediatric mitral regurgitation (MR) in China. From March 2020 to December 2024, consecutive patients younger than 14 years who underwent mitral valve repair at eight representative congenital heart disease centers were enrolled. Eligible patients were those with at least moderate MR on preoperative echocardiography and no prior mitral valve surgery. Patients with uncorrectable concomitant cardiac anomalies, moderate or greater mitral stenosis, ischemic MR, severe leaflet dysplasia, connective tissue disorders (e.g., Barlow, Marfan), cardiomyopathies, or single-ventricle physiology were excluded.

The primary endpoint is a composite of all-cause mortality, reoperation for cardiovascular causes, or recurrence of moderate-or-severe MR during follow-up. Secondary endpoints include perioperative outcomes such as postoperative hospital stay, intensive care unit stay, mechanical ventilation time, and hospitalization cost.

This study is designed to provide high-quality prospective evidence on the safety, durability, and predictors of surgical repair for pediatric MR in a contemporary, real-world, multicenter setting. The findings may inform surgical decision-making and postoperative management strategies for this rare but challenging population.

Enrollment: 427 patients

Sex: All

Ages: Under 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age < 14 years
• No prior mitral valve surgery
• Preoperative echocardiography demonstrating moderate or severe mitral regurgitation

Exclusion criteria

• Concomitant cardiac malformations unable to be corrected simultaneously
• Moderate or severe mitral stenosis
• Ischemic mitral regurgitation
• Severe leaflet dysplasia precluding adequate coaptation
• Connective tissue disorders(e.g., Barlow's disease, Marfan syndrome)
• Any type of cardiomyopathy
• Single ventricle physiology or common atrioventricular valve

Trial design

427 participants in 2 patient groups

Conventional Group

Description:

Those who have undergone conventional mitral valve repair

Treatment:

Procedure: conventional mitral valve repair

Standardized Group

Description:

Those who have undergone standardized mitral valve repair

Treatment:

Procedure: standardized mitral valve repair