Observational Registry to Evaluate Willem AI Platform for ECG Assessment in Adults at High Risk of Cardiac Disease

What this Trial Is About

This research collects extensive clinical data to evaluate the Willem AI platforms performance in interpreting electrocardiograms ECGs from high-risk cardiac patients in real-world healthcare settings. Cardiovascular diseases pose significant public health challenges, and while ECGs are valuable for early detection, their interpretation can be complex, costly, and time-consuming for cardiology experts. Previous trials have assessed Willems AI-based interpretation, but this study aims to gather additional evidence to support its integration into routine care. Participants include high-risk cardiac patients undergoing routine ECGs for arrhythmia or cardiac disease assessment. Enrollment is both retrospective and prospective, with Willem analyzing ECGs automatically without influencing clinical decisions or altering standard care. The platform processes various ECG types and formats, including 12-lead ECGs and recordings from Holters, wearables, and other devices, with specific technical requirements for data quality and length. Participants contribute clinical data and ECG recordings which Willem evaluates for cardiac abnormalities over a period that may extend up to 10 years for prospective cases. The study tracks Willems diagnostic performance compared to standard care ECG evaluations. No interventions alter patient care, and the study focuses on collecting comprehensive data to assess AI interpretation accuracy and utility in clinical practice.

Registry Study for the Evaluation of High-risk Cardiac Patients by WILLEM AI-based ECG Platform