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.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Clinical suspicion of significant low-gradient aortic stenosis
Echocardiographic examination performed for clinical indications
Ability to provide informed consent
Disqualifiers
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
Trial design
Treatments tested in this trial
- AI diagnostic test for severe low-gradient aortic stenosis
Treatment groups
Sponsors and collaborators
National Institute of Cardiology, Warsaw, Poland
Lead sponsor
The Institute of Bioorganic Chemistry, Polish Academy of Sciences
Collaborator