An observational study in Congenital Heart Disease (CHD), Ventricular Septal Defects (VSD) and Cardiac Catheterization, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Recruiting at 1 site in China. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Observational
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.
59 studies on the registry are indexed under Heart Septal Defects, Ventricular; 9 are open to participants now.
This study's planned enrollment of 5,249 is above the median of 100 across 25 observational studies indexed under Heart Septal Defects, Ventricular.
Browse Heart Septal Defects, Ventricular studies →Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 225 studies on the registry; 55 are open to participants now.
Compared within Heart Septal Defects, Ventricular, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Heart Defects, Congenital. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
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Exclusion Criteria:
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.
Time frame: Up to 30 Days After Transcatheter Closure
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 30 Days After Transcatheter Closure
Plan to share: 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.
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Jun 2027, 16 months after the start.
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Heart Septal Defects, Ventricular →
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine →