A Prospective Multicenter Cohort Study on Surgical Treatment Strategies for Pediatric Mitral Regurgitation
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- China National Center for Cardiovascular Diseases
- Enrollment
- 427
- Locations
- 1
- Primary Endpoint
- Composite Primary Endpoint
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Hospitalization Cost(perioperatively)
- Postoperative Hospital Length of Stay(perioperatively)
- ICU Length of Stay(perioperatively)
- Duration of Invasive Mechanical Ventilation(perioperatively)