AI analysis of echocardiograms to identify severe low-gradient aortic stenosis
Artificial Intelligence-Based Assessment of Low-Gradient Aortic Stenosis Severity Using Echocardiographic Images
This project will test an AI tool on clinical echocardiogram images to see if it can reliably identify adults with severe low-gradient aortic stenosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institute of Cardiology, Warsaw, Poland Academic / other |
| Locations | 1 site (Warsaw, Masovian Voivodeship) |
| Trial ID | NCT07144189 on ClinicalTrials.gov |
What this trial studies
This is a prospective multicenter observational validation of an AI model that classifies transthoracic echocardiography images as severe versus moderate low-gradient aortic stenosis. About 300 adults with suspected significant low-gradient aortic stenosis who undergo clinically indicated echocardiography will be enrolled in 2025–2026. Standard imaging will be analyzed by the published AI model but results will not change clinical care; AI classifications will be compared with physicians' assessments to measure diagnostic accuracy and reproducibility. The goal is to determine how the model performs in real-world practice across sites and image quality variations.
Who should consider this trial
Good fit: Adults (≥18 years) with clinical suspicion of significant low-gradient aortic stenosis who are having transthoracic echocardiography and can provide informed consent are ideal candidates.
Not a fit: Patients with prior aortic valve interventions, very poor-quality echocardiographic images, or other severe valvular disease that confounds assessment are excluded and unlikely to benefit from this AI validation.
Why it matters
Potential benefit: If successful, the AI could improve diagnostic accuracy for severe low-gradient aortic stenosis and help ensure appropriate referral for valve intervention.
How similar studies have performed: The investigators' retrospective and published work showed promising diagnostic performance for the model, but prospective multicenter validation in routine practice remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Clinical suspicion of significant low-gradient aortic stenosis * Echocardiographic examination performed for clinical indications * Ability to provide informed consent Exclusion Criteria: * Previous aortic valve intervention (surgical or transcatheter) * Inadequate image quality precluding echocardiographic analysis * Concomitant severe valvular disease (severe mitral stenosis or mitral/aortic regurgitation) that could confound assessment * Patients unwilling or unable to provide informed consent
Where this trial is running
Warsaw, Masovian Voivodeship
- Department of Valvular Heart Disease, National Institute of Cardiology, Warsaw, Poland — Warsaw, Masovian Voivodeship, Poland (Recruiting)
Study contacts
- Principal investigator: Michał Wrzosek, MD — Department of Valvular Heart Disease, National Institute of Cardiology, Warsaw, Poland
- Study coordinator: Michał Wrzosek, MD
- Email: mwrzosek@ikard.pl
- Phone: +48 22 3434189
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.