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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Cardiac Catheterization; Congenital Heart Disease (CHD); Ventricular Septal Defects (VSD)

• Study Type: Observational
• Enrollment (Estimated): 5249

Contacts and Locations

• Study Contact: Name: Kun Sun; Phone Number: 021-13601846338; Email: drsunkun@xinhuamed.com.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200092
      • Recruiting
      • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Contact: Kun Sun; Phone Number: 021-13601846338; Email: drsunkun@xinhuamed.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Up to 30 Days After Transcatheter Closure

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Septal Defects; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Heart Defects, Congenital; Postoperative Complications; Heart Septal Defects, Ventricular
• Other Study ID Numbers: XHEC-C-2025-295-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No