NCT07333547

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200,000 (estimated)
• Sponsor: Idoven 1903 S.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Patient enrollment will be both retrospective and prospective.

Conditions

• High-risk Cardiac Patients

Interventions

Type	Name	Description
DEVICE	Willem AI ECG assessment	There is no study intervention. The Willem AI platform will assess all study ECGs for the identification of cardiac patterns, arrhythmias, and/or cardiac diseases. Regardless of retrospective or prospective enrollment, Willem output will not be provided to the healthcare professional user for clinical evaluation, and therefore routine practice will not be impacted nor altered.

Timeline

• Start date: 2026-02-03
• Primary completion: 2036-01-01
• Completion: 2036-01-01
• First posted: 2026-01-12
• Last updated: 2026-04-13

Locations

4 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated device study