Actively Recruiting

Age: 18Years +
All Genders
NCT07144189

AI Assessment of Low-Gradient Aortic Stenosis Severity Based on Echocardiography

Led by National Institute of Cardiology, Warsaw, Poland · Updated on 2025-12-02

300

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

N

National Institute of Cardiology, Warsaw, Poland

Lead Sponsor

T

The Institute of Bioorganic Chemistry, Polish Academy of Sciences

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate the effectiveness of an artificial intelligence (AI) model developed by the investigators for identifying severe low-gradient aortic valve stenosis. Accurate assessment of stenosis severity is crucial for proper qualification for surgical treatment. It is expected that the use of AI will improve diagnostic accuracy and thereby support better clinical outcomes. Patients with suspected significant low-gradient aortic stenosis will be enrolled. The study is observational and involves no additional risk for participants. Standard imaging studies performed for clinical indications will be additionally analyzed by the AI model, which will classify aortic stenosis as severe or moderate. The model's results will not influence the clinical management of participants but will be compared with physicians' assessments to validate its diagnostic performance. The study will be conducted in 2025-2026. The findings will provide insights into the usefulness of AI in the diagnosis of severe aortic stenosis and may contribute to the development of advanced clinical decision-support tools.

CONDITIONS

Official Title

AI Assessment of Low-Gradient Aortic Stenosis Severity Based on Echocardiography

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 218 years
  • Clinical suspicion of significant low-gradient aortic stenosis
  • Echocardiographic examination performed for clinical indications
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Valvular Heart Disease, National Institute of Cardiology, Warsaw, Poland

Warsaw, Masovian Voivodeship, Poland

Actively Recruiting

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Research Team

M

Michał Wrzosek, MD

CONTACT

T

Tomasz Hryniewiecki, Professor of Medicine

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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