RecruitingNCT07375602

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

ConditionCongenital Heart Disease (CHD), Ventricular Septal Defects (VSD), Cardiac Catheterization, Postoperative Complications
StatusRecruiting
Participants5,249
Est. Completion15 June 2026
Last Updated9 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

China
View Registry Entry

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