Congenital Heart Disease (CHD)NCT07375602
A Multimodal AI Prediction Model for Complications After Transcatheter Closure of Perimembranous VSD in Children
An observational study of Congenital Heart Disease (CHD) and Ventricular Septal Defects (VSD), run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The goal of this observational study is to develop and validate a multimodal artificial intelligence prediction model for treatment-related complications in children with perimembranous ventricular septal defect (pmVSD) undergoing transcatheter device closure. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Congenital Heart Disease (CHD), Ventricular Septal Defects (VSD), Cardiac Catheterization
- How many people
- 5,249 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 30 Dec 2027
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children (18 years or younger) with echocardiography-confirmed perimembranous ventricular septal defect who underwent transcatheter device closure at Xinhua Hospital between January 1, 2015, and December 31, 2025, identified retrospectively from routine clinical care records.
Who may be able to join
- Age ≤ 18 years at the time of transcatheter procedure.
- Diagnosis of perimembranous ventricular septal defect confirmed by echocardiography, and underwent transcatheter device closure at the study center.
- Medical records sufficient to ascertain the primary outcome within the pre-specified follow-up window, and availability of minimum baseline clinical information required for model development/validation.
Who cannot join
- Ventricular septal defects not classified as perimembranous on echocardiography, including muscular, outlet, or inlet VSDs, as well as multiple or complex VSDs involving more than one septal region.
- Presence of complex congenital heart disease or associated structural abnormalities requiring concomitant surgical repair (e.g., tetralogy of Fallot).
- Prior surgical VSD repair or prior transcatheter VSD closure.
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
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Kun Sun, 021-13601846338, drsunkun@xinhuamed.com.cn
About this study
Official title: Multimodal Clinical Data Integration and Artificial Intelligence Modeling for Predicting Complications Following Pediatric Transcatheter Closure of Perimembranous Ventricular Septal Defect
The goal of this observational study is to develop and validate a multimodal artificial intelligence prediction model for treatment-related complications in children with perimembranous ventricular septal defect (pmVSD) undergoing transcatheter device closure. The main question it aims to answer is: Can an AI model that integrates demographics, laboratory results, electronic health record text, echocardiography reports, chest radiographs, and electrocardiogram accurately predict the risk of complications at the individual patient level? Data will be retrospectively collected from routine clinical care records of pediatric patients who underwent transcatheter closure for pmVSD. Deep learning methods will be used to extract features from text and images to train and validate the prediction model.
- Conditions
- Congenital Heart Disease (CHD), Ventricular Septal Defects (VSD), Cardiac Catheterization, Postoperative Complications
- Medical subject headings
- Heart Defects, Congenital, Heart Septal Defects, Ventricular, Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Procedure-Related Complications After Transcatheter Closure of Perimembranous VSD
Occurrence of a composite endpoint of procedure-related complications, including arrhythmia requiring treatment, new-onset or worsened valvular regurgitation, residual shunt requiring reintervention, and device embolization.
Measured: Up to 30 Days After Transcatheter Closure
Secondary outcomes (4)
Area Under the Precision-Recall Curve (AUCPR) for Complication Prediction
The area under the precision-recall curve (AUCPR) of the model for predicting the primary composite procedure-related complication endpoint.
Measured: Up to 30 Days After Transcatheter Closure
Sensitivity of the Model at a Pre-Specified Risk Threshold
Sensitivity for predicting the primary composite procedure-related complication endpoint at a pre-specified probability (risk) threshold.
Measured: Up to 30 Days After Transcatheter Closure
Positive Predictive Value (PPV) of the Model at a Pre-Specified Risk Threshold
Positive predictive value (PPV) for predicting the primary composite procedure-related complication endpoint at the same pre-specified probability (risk) threshold.
Measured: Up to 30 Days After Transcatheter Closure
Negative Predictive Value (NPV) of the Model at a Pre-Specified Risk Threshold
Negative predictive value (NPV) for predicting the primary composite procedure-related complication endpoint at the same pre-specified probability (risk) threshold.
Measured: Up to 30 Days After Transcatheter Closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Feb 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease (CHD)Studies 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
- Retrospective
- Enrolment
- 5,249 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun Sun, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375602
- Sponsor's protocol ID
- XHEC-C-2025-295-1
- Status last verified
- Aug 2026
- First submitted
- 21 Jan 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data will not be made publicly available due to privacy considerations and institutional data governance policies for retrospective electronic health record and imaging data. Aggregated results may be shared in publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Clinical Data Integration and Artificial Intelligence Modeling for Predicting Complications Following Pediatric Transcatheter Closure of Perimembranous Ventricular Septal Defect
- ClinicalTrials.gov ID
- NCT07375602
- Acronym / sponsor ID
- XHEC-C-2025-295-1
- Conditions
- Congenital Heart Disease (CHD), Ventricular Septal Defects (VSD), Cardiac Catheterization, Postoperative Complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,249 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 29 Jan 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 develop and validate a multimodal artificial intelligence prediction model for treatment-related complications in children with perimembranous ventricular septal defect (pmVSD) undergoing transcatheter device closure. The main question it aims to answer is: Can an AI model that integrates demographics, laboratory results, electronic health record text, echocardiography reports, chest radiographs, and electrocardiogram accurately predict the risk of complications at the individual patient level? Data will be retrospectively collected from routine clinical care records of pediatric patients who underwent transcatheter closure for pmVSD. Deep learning methods will be used to extract features from text and images to train and validate the prediction model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children (18 years or younger) with echocardiography-confirmed perimembranous ventricular septal defect who underwent transcatheter device closure at Xinhua Hospital between January 1, 2015, and December 31, 2025, identified retrospectively from routine clinical care records.
Key inclusion criteria (3 listed)
- Age ≤ 18 years at the time of transcatheter procedure.
- Diagnosis of perimembranous ventricular septal defect confirmed by echocardiography, and underwent transcatheter device closure at the study center.
- Medical records sufficient to ascertain the primary outcome within the pre-specified follow-up window, and availability of minimum baseline clinical information required for model development/validation.
Key exclusion criteria (3 listed)
- Ventricular septal defects not classified as perimembranous on echocardiography, including muscular, outlet, or inlet VSDs, as well as multiple or complex VSDs involving more than one septal region.
- Presence of complex congenital heart disease or associated structural abnormalities requiring concomitant surgical repair (e.g., tetralogy of Fallot).
- Prior surgical VSD repair or prior transcatheter VSD closure.
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
Composite Procedure-Related Complications After Transcatheter Closure of Perimembranous VSD
Time frame: Up to 30 Days After Transcatheter Closure
Occurrence of a composite endpoint of procedure-related complications, including arrhythmia requiring treatment, new-onset or worsened valvular regurgitation, residual shunt requiring reintervention, and device embolization.
4 secondary outcomes
Area Under the Precision-Recall Curve (AUCPR) for Complication Prediction
Time frame: Up to 30 Days After Transcatheter Closure
Sensitivity of the Model at a Pre-Specified Risk Threshold
Time frame: Up to 30 Days After Transcatheter Closure
Positive Predictive Value (PPV) of the Model at a Pre-Specified Risk Threshold
Time frame: Up to 30 Days After Transcatheter Closure
Negative Predictive Value (NPV) of the Model at a Pre-Specified Risk Threshold
Time frame: Up to 30 Days After Transcatheter Closure
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 5 Aug 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data will not be made publicly available due to privacy considerations and institutional data governance policies for retrospective electronic health record and imaging data. Aggregated results may be shared in publications and presentations.
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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 (CHD) and Ventricular Septal Defects (VSD), run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 5 Aug 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 Kun Sun (021-13601846338, drsunkun@xinhuamed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Procedure-Related Complications After Transcatheter Closure of Perimembranous VSD (time frame: Up to 30 Days After Transcatheter Closure). 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 5 Aug 2026.