Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT07284212
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:
NCT07284212
Study Brief:
Protocol Section:
NCT07284212