A Multimodal AI Prediction Model for Complications After Transcatheter Closure of Perimembranous VSD in Children

NCT07375602 | Recruiting

• 1 other identifier: XHEC-C-2025-295-1
• Study Type: observational
• Target: 5,249
• Locations: 1 country
• Sites: 1

Brief 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. 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

Cardiac Catheterization; Postoperative Complications; Congenital Heart Disease (CHD); Ventricular Septal Defects (VSD)

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 30 Days After Transcatheter Closure

Secondary Outcomes (4)

• Area Under the Precision-Recall Curve (AUCPR) for Complication Prediction

  Up to 30 Days After Transcatheter Closure

• Sensitivity of the Model at a Pre-Specified Risk Threshold

  Up to 30 Days After Transcatheter Closure

• Positive Predictive Value (PPV) of the Model at a Pre-Specified Risk Threshold

  Up to 30 Days After Transcatheter Closure

• Negative Predictive Value (NPV) of the Model at a Pre-Specified Risk Threshold

  Up to 30 Days After Transcatheter Closure

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital; Heart Septal Defects, Ventricular; Postoperative Complications

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Septal Defects; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kun Sun

CONTACT

021-13601846338; drsunkun@xinhuamed.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Department of Pediatric Cardiology

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: February 1, 2026
• Primary Completion: June 15, 2026
• Study Completion: June 15, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)