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

NCT07284212 | Completed DMC

• 1 other identifier: 2020-FW-MR
• Study Type: observational
• Target: 427
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Mitral Regurgitation; Pediatric Cardiac Surgery; Mitral Valve Repair; Surgical Outcomes

Outcome Measures

Primary Outcomes (1)

• Composite Primary Endpoint

  Time-to-first event of any of the following: (a) all-cause mortality; (b) mitral valve reoperation; or (c) recurrence of ≥ moderate mitral regurgitation on transthoracic echocardiography.

  From date of index surgery until last follow-up (up to 5 years)

Secondary Outcomes (4)

• Postoperative Hospital Length of Stay

  perioperatively

• ICU Length of Stay

  perioperatively

• Duration of Invasive Mechanical Ventilation

  perioperatively

• Hospitalization Cost

  perioperatively

Study Arms (2)

Conventional Group

Those who have undergone conventional mitral valve repair

Procedure: conventional mitral valve repair

Standardized Group

Those who have undergone standardized mitral valve repair

Procedure: standardized mitral valve repair

Interventions

conventional mitral valve repair PROCEDURE

Patients undergoing conventional mitral valve repair, including annuloplasty, leaflet cleft closure, chordal transfer, and chordal resection, et al.

Conventional Group

standardized mitral valve repair PROCEDURE

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.

Standardized Group

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children younger than 14 years with moderate or greater mitral regurgitation undergoing surgical repair at eight representative congenital heart disease centers in China. Eligible patients must not have undergone prior mitral valve surgery and must meet the predefined inclusion and exclusion criteria. The study aims to prospectively evaluate surgical outcomes, durability, and predictors of repair from March 2020 to December 2024, with follow-up completed through September 2025.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Pediatric Cardiac Surgery Center, Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: December 16, 2025
• Study Start: March 18, 2020
• Primary Completion: September 20, 2025
• Study Completion: September 20, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)