NCT07144189

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

Artificial Intelligence-Based Assessment of Low-Gradient Aortic Stenosis Severity Using Echocardiographic Images

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: National Institute of Cardiology, Warsaw, Poland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 the investigators, demonstrated promising diagnostic performance in retrospective data. In the present trial, approximately 300 participants 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.

Conditions

• Low-gradient Aortic Stenosis
• Aortic Stenosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2025-08-20
• Primary completion: 2026-08-20
• Completion: 2026-08-20
• First posted: 2025-08-27
• Last updated: 2025-12-02

Locations

1 site across 1 country: Poland