RecruitingNCT07479992

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


Sponsor

Idoven 1903 S.L.

Enrollment

5,000 participants

Start Date

Apr 28, 2026

Study Type

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

Min Age: 18 Years

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEWillem 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07479992


Related Trials