Congenital Heart DiseaseNCT07524998
A Chinese Multicenter Study on Surgical Techniques and Outcomes Across the Lifespan in Congenital Heart Disease
An observational study of Congenital Heart Disease and Complex Congenital Heart Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Disease, Complex Congenital Heart Disease, Surgery (Cardiac)
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 31 Jan 2029
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, Chinese Academy of Medical Science, PUMC
Beijing, 100037
Shoujun Li, +86 13938701486, drlishoujunfw@163.com
About this study
Official title: 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:
Read more
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.
- Conditions
- Congenital Heart Disease, Complex Congenital Heart Disease, Surgery (Cardiac), Perioperative Care, Quality Control, Health Care
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Identification of key risk factors for CCHD post-surgical recovery
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.
Measured: Retrospective data from baseline pre-surgery to hospital discharge post-surgery at Day 7
Development of a China-specific CCHD surgical quality control system
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Feb 2025
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shoujun Li, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524998
- Sponsor's protocol ID
- 2024ZD0527001
- Status last verified
- Apr 2026
- First submitted
- 19 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Surgical Techniques and Outcomes Across the Lifespan in Congenital Heart Disease Based on a Chinese Multicenter Database
- ClinicalTrials.gov ID
- NCT07524998
- Acronym / sponsor ID
- 2024ZD0527001
- Conditions
- Congenital Heart Disease, Complex Congenital Heart Disease, Surgery (Cardiac), Perioperative Care, Quality Control, Health Care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Complex Congenital Heart Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shoujun Li (+86 13938701486, drlishoujunfw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.