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

Recruiting now

Conditions studied: Low-gradient Aortic Stenosis, Aortic Stenosis

In brief

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.

Key facts

Study ID

NCT07144189

Run by

National Institute of Cardiology, Warsaw, Poland

People needed

300

Starts

2025-08-20

Expected to finish

2026-08-20

Last updated by the study team

2025-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Clinical suspicion of significant low-gradient aortic stenosis
• Echocardiographic examination performed for clinical indications
• Ability to provide informed consent

You may not qualify if…

• 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

Where it is running

• Department of Valvular Heart Disease, National Institute of Cardiology, Warsaw, Poland — Warsaw, Masovian Voivodeship, Poland (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.