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NCT Number: NCT07375602

A Multimodal AI Prediction Model for Complications After Transcatheter Closure of Perimembranous VSD in Children

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.

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Key information

Conditions

Congenital Heart Disease (CHD) Cardiac Catheterization Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Ventricular Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Ventricular Septal Defects (VSD)

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location status: Recruiting

Location contact

Kun Sun

CONTACT

[email protected]

021-13601846338

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Composite Procedure-Related Complications After Transcatheter Closure of Perimembranous VSD

    Time frame: Up to 30 Days After Transcatheter Closure

    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.

Secondary outcomes

  1. Area Under the Precision-Recall Curve (AUCPR) for Complication Prediction

    Time frame: Up to 30 Days After Transcatheter Closure

    The area under the precision-recall curve (AUCPR) of the model for predicting the primary composite procedure-related complication endpoint.

  2. Sensitivity of the Model at a Pre-Specified Risk Threshold

    Time frame: Up to 30 Days After Transcatheter Closure

    Sensitivity for predicting the primary composite procedure-related complication endpoint at a pre-specified probability (risk) threshold.

  3. Positive Predictive Value (PPV) of the Model at a Pre-Specified Risk Threshold

    Time frame: Up to 30 Days After Transcatheter Closure

    Positive predictive value (PPV) for predicting the primary composite procedure-related complication endpoint at the same pre-specified probability (risk) threshold.

  4. Negative Predictive Value (NPV) of the Model at a Pre-Specified Risk Threshold

    Time frame: Up to 30 Days After Transcatheter Closure

    Negative predictive value (NPV) for predicting the primary composite procedure-related complication endpoint at the same pre-specified probability (risk) threshold.

Study contacts

Contact information is provided by the study sponsor or research team.

Kun Sun

CONTACT

[email protected]

021-13601846338

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Multimodal Clinical Data Integration and Artificial Intelligence Modeling for Predicting Complications Following Pediatric Transcatheter Closure of Perimembranous Ventricular Septal Defect

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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