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

NCT07333547 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200000

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • High-risk Cardiac Patients

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.

Sponsors & Collaborators

  • Idoven 1903 S.L.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-03
Primary Completion
2036-01-31
Completion
2036-01-31
FDA Device
Yes

Countries

  • United States
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07333547 on ClinicalTrials.gov