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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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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 30 Days After Transcatheter Closure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 30 Days After Transcatheter Closure |
| Sensitivity of the Model at a Pre-Specified Risk Threshold |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kun Sun | Contact | 021-13601846338 | drsunkun@xinhuamed.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200092 | China |
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.
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Sensitivity for predicting the primary composite procedure-related complication endpoint at a pre-specified probability (risk) threshold. |
| 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. | 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. | Up to 30 Days After Transcatheter Closure |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D006345 | Heart Septal Defects, Ventricular |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006343 | Heart Septal Defects |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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