AI Assessment of Low-Gradient Aortic Stenosis Severity Based on Echocardiography (ASAI-POL)

National Institute of Cardiology, Warsaw, Poland

Status: Not yet enrolling

Conditions: Low-gradient Aortic Stenosis; Aortic Stenosis

Treatments: Diagnostic Test: AI diagnostic test for severe low-gradient aortic stenosis

Study type: Observational

Funder types: Other

Identifiers

NCT07144189

4.35/VI/25

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of an artificial intelligence (AI) model we developed in 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.

Full description

This study is a prospective multicenter observational validation of an artificial intelligence (AI) model for differentiating severe low-gradient from moderate aortic stenosis using transthoracic echocardiography images. The model, developed and published by our group, demonstrated promising diagnostic performance in retrospective data. In the present trial, approximately 300 patients with suspected significant low-gradient aortic stenosis will be enrolled during 2025-2026. Standard imaging studies performed for clinical indications will be analyzed by the AI model, which will classify aortic stenosis as severe or moderate. The AI-derived results will not influence clinical decision-making but will be compared with physicians assessments to evaluate diagnostic accuracy and reproducibility in real-world practice.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

Patients with suspected significant low-gradient aortic stenosis.

Description:

Approximately 300 patients with suspected significant low-gradient aortic stenosis undergoing standard echocardiographic evaluation between 2025 and 2026. Echocardiographic images will be secondarily analyzed by the AI model to classify stenosis as severe or moderate. The AI results will be compared with physicians assessments. No intervention or modification of clinical care is involved.

Treatment:

Diagnostic Test: AI diagnostic test for severe low-gradient aortic stenosis