Multimodal Clinical Data Integration and Artificial Intelligence Modeling for Predicting Complications Following Pediatric Transcatheter Closure of Perimembranous Ventricular Septal Defect
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Trial Details
| Condition | Congenital Heart Disease (CHD), Ventricular Septal Defects (VSD), Cardiac Catheterization, Postoperative Complications |
| Status | Recruiting |
| Participants | 5,249 |
| Est. Completion | 15 June 2026 |
| Last Updated | 9 Apr 2026 |
Primary Outcome
Composite Procedure-Related Complications After Transcatheter Closure of Perimembranous VSD
Eligibility Criteria
Inclusion Criteria
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.
Trial Sites
Countries
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