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

Study acronym: ASAI-POL
StatusRecruiting
PhaseNot specified
Started
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Record status
This record was last updated December 2, 2025 (before its estimated August 20, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Primary and study completion dates: Aug 18, 2026 to Aug 20, 2026
    • Start date changed from estimate of Aug 18, 2025 to Aug 20, 2025
    • Eligibility criteria revised
    • Study description revised
    • Site details revised
    • Collaborators: 2 to 1
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07144189
Lead Sponsor National Institute of Cardiology, Warsaw, Poland
Collaborators: The Institute of Bioorganic Chemistry, Polish Academy of Sciences
Conditions
(from sponsor)
Low-gradient Aortic Stenosis, Aortic Stenosis
Related terms Aortic Valve Stenosis
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov