Multimodal Clinical Data Integration and Artificial Intelligence Modeling for Predicting Complications Following Pediatric Transcatheter Closure of Perimembranous Ventricular Septal Defect
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,249
- 试验地点
- 1
- 主要终点
- Composite Procedure-Related Complications After Transcatheter Closure of Perimembranous VSD
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Composite Procedure-Related Complications After Transcatheter Closure of Perimembranous VSD
时间窗: 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.
次要结局
- Area Under the Precision-Recall Curve (AUCPR) for Complication Prediction(Up to 30 Days After Transcatheter Closure)
- Sensitivity of the Model at a Pre-Specified Risk Threshold(Up to 30 Days After Transcatheter Closure)
- Positive Predictive Value (PPV) of the Model at a Pre-Specified Risk Threshold(Up to 30 Days After Transcatheter Closure)
- Negative Predictive Value (NPV) of the Model at a Pre-Specified Risk Threshold(Up to 30 Days After Transcatheter Closure)
研究者
Kun Sun
Professor of Department of Pediatric Cardiology
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine