A Multimodal AI Prediction Model for Complications After Transcatheter Closure of Perimembranous VSD in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Congenital Heart Disease (CHD), Ventricular Septal Defects (VSD), Cardiac Catheterization, Postoperative Complications. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multimodal Clinical Data Integration and Artificial Intelligence Modeling for Predicting Complications Following Pediatric Transcatheter Closure of Perimembranous Ventricular Septal Defect
Overview
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.
Primary outcome measures
- Composite Procedure-Related Complications After Transcatheter Closure of Perimembranous VSD [Time frame: Up to 30 Days After Transcatheter Closure]
Secondary outcome measures (4)
- Area Under the Precision-Recall Curve (AUCPR) for Complication Prediction [Time frame: Up to 30 Days After Transcatheter Closure]
- Sensitivity of the Model at a Pre-Specified Risk Threshold [Time frame: Up to 30 Days After Transcatheter Closure]
- Positive Predictive Value (PPV) of the Model at a Pre-Specified Risk Threshold [Time frame: Up to 30 Days After Transcatheter Closure]
- Negative Predictive Value (NPV) of the Model at a Pre-Specified Risk Threshold [Time frame: Up to 30 Days After Transcatheter Closure]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT07375602 · XHEC-C-2025-295-1