Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT07479992

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

Led by Idoven 1903 S.L. · Updated on 2026-05-12

5000

Participants Needed

2

Research Sites

9 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 218 years
  • All available 12-lead ECGs with a minimum length of 10 seconds in raw 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
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Universitätsklinikum Bonn

Bonn, Germany

Actively Recruiting

2

Technical University of Munich

Munich, Germany

Not Yet Recruiting

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Research Team

M

Manuel Marina-Breysse, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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