Actively Recruiting
Evaluation of Surgical Techniques and Outcomes Across the Lifespan in Congenital Heart Disease Based on a Chinese Multicenter Database
Led by China National Center for Cardiovascular Diseases · Updated on 2026-04-13
3000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying recovery after heart surgery for people with Complex Congenital Heart Disease (CCHD) to understand the main risk factors affecting recovery. The study also aims to build a comprehensive data platform to support CCHD care throughout a person's life and develop a China-specific quality control system to improve surgical outcomes and guide national health policies. The study includes two groups: a retrospective group of 2,494 patients who already had CCHD surgery and are in an existing national database, and a prospective group of 1,940 patients scheduled for surgery as part of related sub-studies. Data collected include pre-surgery tests, surgical details, care during and after surgery, and follow-up for up to one year. Researchers will combine data from both groups to build a new registry and quality control system. Participants will have their medical records analyzed or have data collected during their care, depending on their group. Researchers will monitor recovery and outcomes up to one year after surgery, using the combined data to identify risk factors and develop a surgical quality control system. The study spans up to 48 months, aiming to improve CCHD care across all ages in China.
CONDITIONS
Brief Title
A Chinese Multicenter Study on Surgical Techniques and Outcomes Across the Lifespan in Congenital Heart Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Lost to follow-up
- More than 30% missing core clinical data
- Severe extracardiac malformations, systemic dysfunction, or other conditions that prevent study participation according to sub-study specific criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days post-surgery
Participants undergo surgical intervention for Complex Congenital Heart Disease and receive immediate post-operative care including hospital stay until discharge.
Hospital stay with daily assessments until discharge
Duration - Up to 1 year post-surgery
Participants are followed for recovery and health outcomes for up to 1 year after surgery to monitor progress and optimize care.
Regular follow-up visits over 1 year
Trial Site Locations
Total: 1 location
1
Fuwai Hospital, Chinese Academy of Medical Science, PUMC
Beijing, China, 100037
Actively Recruiting
Research Team
S
Shoujun Li
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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