Study of Willem17 AI Software for ECG Analysis in Patients With High-Risk Cardiac Conditions

What this Trial Is About

The WILLEM study is a multicenter observational trial focusing on high-risk cardiac patients with arrhythmias or abnormal ECG patterns. It aims to validate a cloud-based AI-powered ECG analysis platform called Willem173, which is designed to detect and predict cardiac abnormalities. The study compares the AI diagnoses with cardiologists evaluations and assesses the platforms ability to delay or avoid severe cardiac events such as sudden death. Participants include patients with relevant cardiac arrhythmias or diseases and at least one ECG record with over one year of follow-up data. Participants are divided into two groups a training group to develop new AI methodologies and a test group to evaluate the AIs performance and avoid overfitting. The AI platform analyzes cardiac electrical signals lasting 10 seconds or more, collected from various devices including hospital ECG machines, Holter monitors, wearable ECG patches, and telemedicine interfaces. Cardiology experts review all data to label arrhythmias and patterns. Both retrospective and prospective patient data are used. During the study, participants provide ECG data and clinical information for analysis. Researchers monitor primary outcomes such as real-time detection of cardiac arrhythmias within minutes of ECG recording. Secondary outcomes include survival, major cardiovascular events, rehospitalization, and quality of life measured one year after the initial ECG or enrollment. Informed consent is obtained from patients or authorized relatives if patients cannot consent themselves. The study is conducted until November 2026, with ongoing data collection and evaluation.

AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)