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NOT YET RECRUITING
NCT07333547

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

Sponsor: Idoven 1903 S.L.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200000

Start Date

2026-02

Completion Date

2036-01

Last Updated

2026-01-12

Healthy Volunteers

Yes

Interventions

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.

Locations (3)

La Paz University Hospital

Madrid, Spain

Puerta de Hierro University Hospital

Madrid, Spain

Murcia University

Murcia, Spain