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NCT Number: NCT07524998

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

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Complex Congenital Heart Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Health Care Heart Defects, Congenital Heart Diseases Perioperative Care Quality Control Surgery (Cardiac)

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Hospital, Chinese Academy of Medical Science, PUMC

Beijing, 100037, China

Location status: Recruiting

Location contact

Shoujun Li

CONTACT

[email protected]

+86 13938701486

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.
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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shoujun Li

CONTACT

[email protected]

+86 13938701486

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2029
Study completion: 2029
First posted: Apr 13, 2026
Registry last updated: Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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