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

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.

NCT Number	NCT07144189
Lead Sponsor	National Institute of Cardiology, Warsaw, Poland Collaborators: The Institute of Bioorganic Chemistry, Polish Academy of Sciences
Conditions	Low-gradient Aortic Stenosis, Aortic Stenosis
Enrollment	300 participants
Start Date	2025-08-20
Primary Completion	2026-08-20 (estimated)
Study Completion	2026-08-20 (estimated)
Updated on ClinicalTrials.gov	2025-12-02