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

April 10, 2026 updated by: Shoujun Li, China National Center for Cardiovascular Diseases

Evaluation of Surgical Techniques and Outcomes Across the Lifespan in Congenital Heart Disease Based on a Chinese Multicenter Database

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100037
        • Recruiting
        • Fuwai Hospital, Chinese Academy of Medical Science, PUMC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Lost to follow-up
  • >30% missing core clinical data
  • Severe extracardiac malformations, systemic dysfunction, or other conditions precluding study participation, per sub-study specific exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of key risk factors for CCHD post-surgical recovery
Time Frame: Retrospective data from baseline pre-surgery to hospital discharge post-surgery at Day 7
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
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

January 31, 2029

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024ZD0527001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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