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 o
| Condition(s) | Low-gradient Aortic Stenosis, Aortic Stenosis |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 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 part |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | National Institute of Cardiology, Warsaw, Poland |
| Locations | Warsaw, Masovian Voivodeship, Poland |
| Start date | 2025-08-20 |
| NCT ID | NCT07144189 |
| Official listing | https://clinicaltrials.gov/study/NCT07144189 |