Clinical trial Recruiting at 1 site Observational Ages 18 and up

AI analysis of echocardiograms to identify severe low-gradient aortic stenosis

Official title: Artificial Intelligence-Based Assessment of Low-Gradient Aortic Stenosis Severity Using Echocardiographic Images

Run by National Institute of Cardiology, Warsaw, Poland · NCT07144189 · Data updated 2026-11-12

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 typeObservational
Ages18 Years and up
SexAll
Enrollment300 (estimated)
SponsorNational Institute of Cardiology, Warsaw, Poland
Academic / other
Locations1 site (Warsaw, Masovian Voivodeship)
StatusRecruiting
StartedAugust 20, 2025
Main results expectedAugust 20, 2026
Study endsAugust 20, 2026
Registry record updatedDecember 2, 2025
Trial IDNCT07144189 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: The investigators' retrospective and published work showed promising diagnostic performance for the model, but prospective multicenter validation in routine practice remains limited.

Who can join: the full rules

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 it's running

  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.