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

ConditionAortic Stenosis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorIdoven 1903 S.L.

About this trial

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 criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

Willem AI ECG assessment

Treatment groups

5,000 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Idoven 1903 S.L.

Lead sponsor

Source ClinicalTrials.gov