Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram Study
Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram (Willem AoS-SEDAI) Study
Idoven 1903 S.L.
5,000 participants
Apr 28, 2026
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Age ≥ 18 years;
- All available 12-lead ECG with a 10 seconds minimum length on raw data digital format will be included
- Available clinical data corresponding to each ECG to confirm patient demographics and Aortic Stenosis diagnosis
- Available transthoracic echocardiogram (TTE) within +/- 90 days of each ECG recording
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Interventions
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.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07479992