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

July 17, 2026 updated by: Idoven 1903 S.L.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Aortic Stenosis (AS) is a common and progressive valvular heart disease, especially in older adults, yet significantly underdiagnosed. Many individuals with significant AS may remain asymptomatic for extended periods or experience vague symptoms, delaying diagnosis for several years. In some cases, sudden cardiac events or decompensation may be the first indication of advanced AS, particularly in those who have not undergone regular cardiovascular evaluation.

The primary method for diagnosing AS is echocardiography, which allows visualization of valve anatomy and assessment of transvalvular gradients. However, reliance on symptom reporting or late-stage signs, that trigger a provider to order an echo, can result in missed opportunities for earlier detection. Additionally, electrocardiographic changes-such as left ventricular hypertrophy or strain patterns-can often be detected before structural abnormalities are visible on imaging studies. This delay between electrical changes evolution and later structural findings creates a valuable opportunity to intervene sooner, for example with a valve replacement. This diagnostic latency highlights a critical window where early identification through Artificial Intelligence (AI) analysis of electrocardiograms (ECGs) and timely referral to cardiology can significantly alter disease trajectory and improve outcomes, especially in primary care and community health settings.

AoS-SEDAI study is an observational, retrospective and prospective, multicenter clinical study. Even though controls will be distinguished from AS patients for ground truth and performance evaluation, this is a single-arm study since there are no differences in study interventions.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Manuel Marina-Breysse, MD, PhD
  • Phone Number: +34669752391
  • Email: clinical@idoven.ai

Study Locations

  • Germany
      • Bonn, Germany
        • Recruiting
        • Universitätsklinikum Bonn
        • Contact:
          • Sebastian Zimmer, MD, PhD
      • Munich, Germany
        • Recruiting
        • Technical University of Munich
        • Contact:
          • Tobias Rheude, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The target population consists of patients under assessment of Aortic Stenosis (AS).

Screened patients need to have 12-lead ECG recordings within 90 days of a transthoracic echocardiogram (TTE). In the case of multiple ECGs and TTEs per patient, all of them will be selected and analysed accordingly considering the corresponding PI diagnosis at each time. In the event of a patient with a different diagnosis over time (e.g. non-AS confirmed diagnosis later on diagnosed with AS), multiple timepoint ECGs will be categorized so that the same patient is not included both in the control and in the AS populations.

Controls will include non-AS patients with relevant TTE and clinical findings during AS differential diagnosis (such as hypertensive heart disease, structural heart diseases, hypertrophic cardiomyopathy among other cardiomyopathies, mild aortic stenosis, and no significant aortic leaflet calcification).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Aortic Stenosis patients
Subjects with an Aortic Stenosis diagnosis confirmed by the physician following their routine practice (e.g. ESC Guidelines), including complete clinical assessment with echocardiogram or other complementary techniques.
Device: 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.
Non-Aortic Stenosis patients (Controls)
Subjects without Aortic Stenosis confirmed by the physician after thorough evaluation following their routine practice.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Willem performance to detect severe Aortic Stenosis
Time Frame: ECG will be performed at baseline, and ECG analysis by Willem AI will be performed retrospectively throughout the trial, and finalized upon recruitment completion.

Performance of Willem AI platform to distinguish between severe Aortic Stenosis (AS) patients with confirmed diagnosis and non-AS patients, by means of the following performance metrics: Area Under the Receiver Operating Characteristic curve (AUROC), diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).

The Standard Of Care (SOC) investigator diagnosis will be used as the ground truth.
ECG will be performed at baseline, and ECG analysis by Willem AI will be performed retrospectively throughout the trial, and finalized upon recruitment completion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Willem performance to detect moderate Aortic Stenosis
Time Frame: ECG will be performed at baseline, and ECG analysis by Willem AI will be performed retrospectively throughout the trial, and finalized upon recruitment completion.
Performance of Willem AI platform to distinguish between moderate Aortic Stenosis (AS) patients with confirmed diagnosis and non-AS patients, by means of the following performance metrics: Area Under the Receiver Operating Characteristic curve (AUROC), diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). The Standard Of Care (SOC) investigator diagnosis will be used as the ground truth.
ECG will be performed at baseline, and ECG analysis by Willem AI will be performed retrospectively throughout the trial, and finalized upon recruitment completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Idoven 1903 S.L.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AoS-SEDAI_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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