RecruitingNCT07333547

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


Sponsor

Idoven 1903 S.L.

Enrollment

200,000 participants

Start Date

Feb 3, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Willem AI ECG assessment for people with high-risk cardiac patients. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEWillem 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(5)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

CardioHeredia

Guayaquil, Guayas, Ecuador

La Paz University Hospital

Madrid, Spain

Puerta de Hierro University Hospital

Madrid, Spain

Murcia University

Murcia, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07333547