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

NCT07144189 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-12-02

No results posted yet for this 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.

Conditions

  • Low-gradient Aortic Stenosis
  • Aortic Stenosis

Interventions

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.

Sponsors & Collaborators

  • The Institute of Bioorganic Chemistry, Polish Academy of Sciences

    collaborator UNKNOWN

  • National Institute of Cardiology, Warsaw, Poland

    lead OTHER

Principal Investigators

  • Tomasz Hryniewiecki, Professor of Medicine · Department of Valvular Heart Disease, National Institute of Cardiology, Warsaw, Poland

  • Michał Wrzosek, MD · Department of Valvular Heart Disease, National Institute of Cardiology, Warsaw, Poland

  • Karina Zatorska, MD, PhD · Department of Valvular Heart Disease, National Institute of Cardiology, Warsaw, Poland

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-20
Primary Completion
2026-08-20
Completion
2026-08-20

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07144189 on ClinicalTrials.gov