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

NCT ID: NCT07284212

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

427 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-18

Study Completion Date

2025-09-20

Brief Summary

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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.

Detailed Description

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Conditions

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Mitral Regurgitation (MR) Pediatric Cardiac Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Conventional Group

Those who have undergone conventional mitral valve repair

conventional mitral valve repair

Intervention Type PROCEDURE

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

Standardized Group

Those who have undergone standardized mitral valve repair

standardized mitral valve repair

Intervention Type 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.

Interventions

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conventional mitral valve repair

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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pediatric Cardiac Surgery Center, Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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2020-FW-MR

Identifier Type: -

Identifier Source: org_study_id