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NCT Number: NCT07284212

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

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.

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Key information

Conditions

Mitral Regurgitation (MR) Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency Pediatric Cardiac Surgery

Age range

Up to 14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pediatric Cardiac Surgery Center, Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conventional mitral valve repair

Procedure

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

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.

Primary outcomes

  1. Composite Primary Endpoint

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

    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.

Secondary outcomes

  1. Postoperative Hospital Length of Stay

    Time frame: perioperatively

    Total postoperative days from surgery to hospital discharge.

  2. ICU Length of Stay

    Time frame: perioperatively

    Consecutive time in intensive care unit.

  3. Duration of Invasive Mechanical Ventilation

    Time frame: perioperatively

    Cumulative duration of invasive mechanical ventilation during the index hospitalization, including all episodes of intubation and re-intubation.

  4. Hospitalization Cost

    Time frame: perioperatively

    Total in-hospital medical cost for the index surgical admission (local currency), extracted from billing records.

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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