Status:
RECRUITING
AI Assessment of Low-Gradient Aortic Stenosis Severity Based on Echocardiography
Lead Sponsor:
National Institute of Cardiology, Warsaw, Poland
Collaborating Sponsors:
The Institute of Bioorganic Chemistry, Polish Academy of Sciences
Conditions:
Low-gradient Aortic Stenosis
Aortic Stenosis
Eligibility:
All Genders
18+ years
Brief Summary
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 a...
Detailed Description
This study is a prospective multicenter observational validation of an artificial intelligence (AI) model for differentiating severe low-gradient from moderate aortic stenosis using transthoracic echo...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Clinical suspicion of significant low-gradient aortic stenosis
- Echocardiographic examination performed for clinical indications
- Ability to provide informed consent
Exclusion
- 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
Key Trial Info
Start Date :
August 20 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 20 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07144189
Start Date
August 20 2025
End Date
August 20 2026
Last Update
December 2 2025
Active Locations (1)
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1
Department of Valvular Heart Disease, National Institute of Cardiology, Warsaw, Poland
Warsaw, Masovian Voivodeship, Poland