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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
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 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Clinical suspicion of significant low-gradient aortic stenosis

• Echocardiographic examination performed for clinical indications

• Ability to provide informed consent

Locations
Other Locations
Poland
Department of Valvular Heart Disease, National Institute of Cardiology, Warsaw, Poland
RECRUITING
Warsaw
Contact Information
Primary
Michał Wrzosek, MD
mwrzosek@ikard.pl
+48 22 3434189
Backup
Tomasz Hryniewiecki, Professor of Medicine
thryniewiecki@ikard.pl
+48 223434180
Time Frame
Start Date: 2025-08-20
Estimated Completion Date: 2026-08-20
Participants
Target number of participants: 300
Treatments
Patients with suspected significant low-gradient aortic stenosis.
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.
Related Therapeutic Areas
Sponsors
Collaborators: The Institute of Bioorganic Chemistry, Polish Academy of Sciences
Leads: National Institute of Cardiology, Warsaw, Poland

This content was sourced from clinicaltrials.gov