AI prediction of complications after transcatheter closure of perimembranous VSD in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This retrospective observational project will develop and validate a multimodal artificial intelligence model to predict treatment-related complications after transcatheter device closure for perimembranous ventricular septal defect in children. Researchers will extract demographics, laboratory results, electronic health record text, echocardiography reports, chest radiographs, and electrocardiograms from routine clinical records and use deep learning to pull features from text and images. The model will be trained and validated on cases from a single center with outcomes ascertained within a prespecified follow-up window. The aim is to generate individualized risk estimates that can inform monitoring and clinical decision-making.

Why it matters

Who can join: the full rules

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.

Where it's running

• Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Kun Sun
• Email: drsunkun@xinhuamed.com.cn
• Phone: 021-13601846338

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.