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

Conditions

• High-risk Cardiac Patients

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Willem AI ECG assessment — DEVICE
  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.

Study Details

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 Dates

Start date

Feb 3, 2026

Status verified

Dec 2025

Primary completion

Jan 31, 2036

Completion

Jan 31, 2036

Study Design

Enrollment

200,000 participants (estimated)

Arms

• Arm: High-risk cardiac patients
  High-risk cardiac patients undergoing routine care electrocardiogram (ECG) for assessment of arrhythmias or cardiac diseases
• Arm: Controls
  In case of any cardiac disease diagnosed to the high-risk cardiac patient cohort, controls will be any enrolled patient with no confirmed diagnosis of such cardiac disease

Primary Outcome Measure

Primary endpoint analysis: Willem performance [ Time Frame: From enrollment to any standard of care timepoint when the patient underwent (retrospective) or will undergo within the next 10 years (prospective) an eligible electrocardiogram ]

Central Contacts

• Manuel Marina-Breysse, MD, PhD
  +34669752391
  [email protected]

Locations (1)

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