Willem AI for early detection of aortic stenosis from a 12‑lead ECG
Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram (Willem AoS-SEDAI) Study
This project will test whether the Willem AI can detect aortic stenosis from routine 12‑lead ECGs in adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Idoven 1903 S.L. Industry-sponsored |
| Locations | 2 sites (Bonn and 1 other locations) |
| Trial ID | NCT07479992 on ClinicalTrials.gov |
What this trial studies
This is a multicenter observational study using both retrospective and prospective ECG data to validate the Willem AI algorithm's ability to distinguish aortic stenosis from non‑AS patients. De‑identified digital 12‑lead ECG recordings of at least 10 seconds will be paired with clinical data and a transthoracic echocardiogram performed within ±90 days to establish ground truth. The algorithm's ECG-based classifications will be compared to echocardiographic diagnoses across participating centers in Germany. No exclusion criteria are defined beyond the required ECG and echocardiogram availability.
Who should consider this trial
Good fit: Adults (≥18 years) with available digital 12‑lead ECGs (≥10 seconds) and a transthoracic echocardiogram performed within ±90 days of the ECG are the intended participants.
Not a fit: People under 18, those without digital 12‑lead ECGs or without a TTE within the specified ±90‑day window, and patients lacking the required clinical data would not be eligible or benefit from this validation.
Why it matters
Potential benefit: If successful, the AI could enable earlier, more scalable detection of aortic stenosis from routine ECGs and prompt timely referral for echocardiography and treatment.
How similar studies have performed: Prior AI‑ECG research has shown promise in detecting structural heart disease and reduced ejection fraction, and initial reports suggest similar approaches may identify aortic stenosis, but large multicenter validation remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 No exclusion criteria are defined for this study.
Where this trial is running
Bonn and 1 other locations
- Universitätsklinikum Bonn — Bonn, Germany (Recruiting)
- Technical University of Munich — Munich, Germany (Not_yet_recruiting)
Study contacts
- Study coordinator: Manuel Marina-Breysse, MD, PhD
- Email: clinical@idoven.ai
- Phone: +34669752391
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.