MedTrace Logo

Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram Study

NCT07479992 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2026-05-12

No results posted yet for this study

Summary

AoS-SEDAI study is an observational, multicenter, retrospective and prospective clinical study.

This study aims to assess Willem Artificial Intelligence (AI) ability to distinguish between aortic stenosis (AS) and non-AS patients from 12-lead electrocardiogram (ECG) data.

Conditions

  • Aortic Stenosis

Interventions

DEVICE

Willem AI ECG assessment

There is no study intervention. The Willem AI platform will assess all study electrocardiograms (ECGs) for the identification of aortic stenosis. 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
2026-04-28
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Germany

Study Locations

More Related Trials

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 NCT07479992 on ClinicalTrials.gov