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RECRUITINGOBSERVATIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥ 18 years - Clinical suspicion of significant low-gradient aortic stenosis - Echocardiographic examination performed for clinical indications - Ability to provide willing to sign a consent form Who Should NOT Join This Trial: - 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 willing to sign a consent form Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIAGNOSTIC_TEST

AI diagnostic test for severe low-gradient aortic stenosis

All participants will undergo standard transthoracic echocardiography performed for clinical indications. Echocardiographic images will be analyzed both by experienced physicians and by the investigational AI model. Additional diagnostic tests (such as cardiac CT, low-dose dobutamine stress echocardiography or transesophageal echocardiography) may be performed if clinically indicated, according to current guideline recommendations. The AI-derived results will not influence clinical decision-making.

Locations (1)

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