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

The WILLEM Registry is a large-scale, single-group, observational, registry study to collect continuous clinical evidence of Willem in real-world settings. Cardiovascular diseases are a major problem for public health and healthcare systems. Electrocardiograms (ECGs) are simple tests which increase diagnostic performance and early detection of cardiovascular diseases. However, its interpretation is complex, time consuming for cardiology experts, and entails high costs for healthcare systems. Willem allows AI-based automatic interpretation and its performance has been examined in previous clinical trials, but additional clinical evidence is needed for its integration in real-world clinical settings. This study will collect clinical evidence of Willem performance to detect cardiac abnormalities in ECGs from high-risk cardiac patients admitted to cardiovascular units.

NCT Number	NCT07333547
Lead Sponsor	Idoven 1903 S.L.
Conditions	High-risk Cardiac Patients
Enrollment	200,000 participants
Start Date	2026-02-03
Primary Completion	2036-01 (estimated)
Study Completion	2036-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-20