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

Idoven

Status: Not yet enrolling

Conditions: Aortic Stenosis

Treatments: Device: Willem AI ECG assessment

Study type: Observational

Funder types: Industry

Identifiers

NCT07479992

AoS-SEDAI_01

Details and patient eligibility

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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.

Trial design

5,000 participants in 2 patient groups

Aortic Stenosis patients

Description:

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.

Treatment:

Device: Willem AI ECG assessment

Non-Aortic Stenosis patients (Controls)

Description:

Subjects without Aortic Stenosis confirmed by the physician after thorough evaluation following their routine practice.

Treatment:

Device: Willem AI ECG assessment