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临床试验/NCT07284212
NCT07284212已完成不适用

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

China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 427 人开始时间: 2020年3月18日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
427
试验地点
1
主要终点
Composite Primary Endpoint

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Composite Primary Endpoint

时间窗: 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.

次要结局

  • Hospitalization Cost(perioperatively)
  • Postoperative Hospital Length of Stay(perioperatively)
  • ICU Length of Stay(perioperatively)
  • Duration of Invasive Mechanical Ventilation(perioperatively)

研究者

发起方
China National Center for Cardiovascular Diseases
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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