A Chinese Multicenter Study on Surgical Techniques and Outcomes Across the Lifespan in Congenital Heart Disease

NCT07524998 | Recruiting DMC

• 1 other identifier: 2024ZD0527001
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about recovery after heart surgery for people with Complex Congenital Heart Disease (CCHD), build a comprehensive data platform for CCHD care across a person's whole life, and create a China-specific quality control system to improve CCHD surgical care. The main questions it aims to answer are: What are the main risk factors that affect how well people with CCHD recover after heart surgery? Can a whole life course, multi-dimensional data platform for CCHD care be built to support better clinical quality control? Can a China-specific system to evaluate and control the quality of CCHD heart surgery be developed to guide national health policies and improve patient outcomes? Participants in this study are people with CCHD who have had or will have heart surgery at participating medical centers. This includes two groups: A retrospective group: People who already had CCHD heart surgery and were included in the existing National Congenital Heart Disease Surgery Database. A prospective group: People who are scheduled to have CCHD heart surgery as part of related sub-studies of this project. People who are lost to follow-up or have more than 30% missing data will not be included. Participants will: For the retrospective group: Have their past medical records (from surgery and follow-up) analyzed by researchers to find risk factors linked to recovery after CCHD heart surgery. For the prospective group: Have their pre-surgery tests, surgery details, care during and after surgery, and follow-up data (including up to 1 year after surgery) collected as part of their regular medical care. Researchers will combine data from both groups into a new registry, work with a third-party committee to check data quality, and use this combined data to build a quality control and evaluation system for CCHD heart surgery. This system will help show the current state of CCHD care in China and guide national health decisions.

Conditions

Congenital Heart Disease; Complex Congenital Heart Disease; Perioperative Care; Quality Control; Health Care; Surgery (Cardiac)

Outcome Measures

Primary Outcomes (2)

• Identification of key risk factors for CCHD post-surgical recovery

  To identify and validate 5 key risk factors linked to perioperative adverse events and post-surgical recovery in patients with Complex Congenital Heart Disease (CCHD) using retrospective cohort data.

  Retrospective data from baseline pre-surgery to hospital discharge post-surgery at Day 7

• Development of a China-specific CCHD surgical quality control system

  To establish a China-specific quality control and evaluation system for CCHD surgical care, which will reflect variations in CCHD care across disease subtypes, age groups, and regions, and guide improvements in clinical outcomes, medical resource use, and patient quality of life.

  From baseline (pre-surgery) until 1 year post-surgery for each enrolled participant, assessed over the entire study period of up to 48 months from study initiation

Study Arms (2)

Retrospective cohort

This cohort includes 2,494 patients with Complex Congenital Heart Disease (CCHD) who underwent surgical intervention and were enrolled in the National Congenital Heart Disease Surgery Database. Researchers will use multivariable regression models to identify key risk factors affecting post-surgical recovery outcomes, and optimize perioperative data collection for CCHD care based on these findings.

Prospective cohort

This cohort includes 1,940 patients with Complex Congenital Heart Disease (CCHD) scheduled for surgical intervention from related sub-studies of this project. Researchers will collect comprehensive, multi-dimensional data across the entire care continuum, including preoperative evaluations, surgical procedures, perioperative management, and 1-year follow-up outcomes, as well as extend data collection to fetal and adult CCHD populations. This registry platform will support related sub-studies and contribute to the development of a nationwide multi-center CCHD cohort and China-specific surgical quality control system.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study population includes two cohorts of patients with Complex Congenital Heart Disease (CCHD) undergoing surgical intervention: 1. Retrospective cohort: Patients with CCHD who were enrolled in National Congenital Heart Disease Surgery Database and had received cardiac surgery. 2. Prospective cohort: Consecutive patients with CCHD scheduled for surgical intervention as part of related sub-studies of this project, recruited from participating medical centers across China.

You may qualify if:

• Clinical diagnosis of Complex Congenital Heart Disease (CCHD) who underwent surgical intervention and were enrolled in the 13th Five-Year Plan National Congenital Heart Disease Surgery Database
• Clinical diagnosis of CCHD requiring surgical/intrauterine intervention or cardiac rehabilitation
• Willing to sign informed consent and complete follow-up

You may not qualify if:

• Lost to follow-up
• \>30% missing core clinical data

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Science, PUMC

Beijing, 100037, China

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Shoujun Li

CONTACT

+86 13938701486; drlishoujunfw@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Professor

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: April 13, 2026
• Study Start: February 1, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CN (1)