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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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 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

Primary outcome measure(s)

• Area Under the Receiver Operating Characteristic Curve (AUC) describing the sensitivity-specificity relationship of the AI model. — At the time of the nearest Heart Team meeting following the echocardiographic examination (typically within 1 week).
  AUC will be calculated to assess the ability of the AI model to differentiate between severe low-gradient and moderate aortic stenosis. The analysis will use physician assessment and guideline-based diagnostic criteria as the reference standard. AUC will be reported with 95% confidence intervals.

Trial sites (1)

More National Institute of Cardiology, Warsaw, Poland trials in Poland

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