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Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram Study
Sponsor: Idoven 1903 S.L.
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.
Official title: Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram (Willem AoS-SEDAI) Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
5000
Start Date
2026-03
Completion Date
2026-06
Last Updated
2026-03-20
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (2)
Universitätsklinikum Bonn
Bonn, Germany
Technical University of Munich
Munich, Germany