Surgical techniques and outcomes across the lifespan in congenital heart disease in China
Evaluation of Surgical Techniques and Outcomes Across the Lifespan in Congenital Heart Disease Based on a Chinese Multicenter Database
See which surgical factors and care patterns affect recovery after heart surgery for people with complex congenital heart disease in China.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07524998 on ClinicalTrials.gov |
What this trial studies
This multicenter observational project will enroll people with complex congenital heart disease (CCHD) who have had or will have cardiac surgery at participating Chinese centers, combining retrospective cases from the national database with prospective follow-up. Investigators will collect clinical, surgical, perioperative, and longitudinal outcome data and integrate them into a multi-dimensional, life-course data platform. The dataset will be analyzed to identify main risk factors for postoperative recovery and to develop China-specific quality control metrics for CCHD surgical care. Results are intended to guide clinical quality improvement and inform national health policy.
Who should consider this trial
Good fit: People with complex congenital heart disease who have undergone or plan to undergo cardiac surgery at a participating center and who can provide informed consent and complete follow-up.
Not a fit: Patients with severe extracardiac malformations or systemic dysfunction that preclude participation, those lost to follow-up, or those with large amounts of missing core clinical data may not benefit from the study's findings.
Why it matters
Potential benefit: If successful, this could produce China-specific surgical quality standards and care pathways that reduce complications and improve long-term outcomes for people with CCHD.
How similar studies have performed: Large congenital cardiac surgical registries and quality collaboratives elsewhere (for example, the STS congenital database) have led to measurable improvements, but a China-specific, life-course CCHD data platform is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing
- Fuwai Hospital, Chinese Academy of Medical Science, PUMC — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Shoujun Li
- Email: drlishoujunfw@163.com
- Phone: +86 13938701486
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.