Congenital Heart Disease (CHD) Clinical Trials

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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Fuwai Hospital, Chinese Academy of Medical Science, PUMC
RECRUITING
Beijing
Contact Information
Primary
Shoujun Li
drlishoujunfw@163.com
+86 13938701486
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2029-01-31
Participants
Target number of participants: 3000
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: China National Center for Cardiovascular Diseases

This content was sourced from clinicaltrials.gov