NCT07284212

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 427 (actual)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Mitral Regurgitation (MR)
• Pediatric Cardiac Surgery

Interventions

Type	Name	Description
PROCEDURE	conventional mitral valve repair	Patients undergoing conventional mitral valve repair, including annuloplasty, leaflet cleft closure, chordal transfer, and chordal resection, et al.
PROCEDURE	standardized mitral valve repair	Patients undergoing the standardized mitral valve repair strategy proposed by Professor Li at Fuwai Hospital in 2016, which involves comprehensive exploration and correction of abnormalities at the subvalvular, leaflet, and annular levels.

Timeline

• Start date: 2020-03-18
• Primary completion: 2025-09-20
• Completion: 2025-09-20
• First posted: 2025-12-16
• Last updated: 2025-12-16

Locations

1 site across 1 country: China