NCT07144189 AI Assessment of Low-Gradient Aortic Stenosis Severity Based on Echocardiography
| NCT ID | NCT07144189 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Cardiology, Warsaw, Poland |
| Condition | Low-gradient Aortic Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-08-20 |
| Primary Completion | 2026-08-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-08-20 with a primary completion date of 2026-08-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Tomasz Hryniewiecki, Professor of Medicine
STUDY CHAIR
Department of Valvular Heart Disease, National Institute of Cardiology, Warsaw, Poland
Frequently Asked Questions
Who can join the NCT07144189 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Low-gradient Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07144189 currently recruiting?
Yes, NCT07144189 is actively recruiting participants. Contact the research team at mwrzosek@ikard.pl for enrollment information.
Where is the NCT07144189 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT07144189 clinical trial?
NCT07144189 is sponsored by National Institute of Cardiology, Warsaw, Poland. The principal investigator is Tomasz Hryniewiecki, Professor of Medicine at Department of Valvular Heart Disease, National Institute of Cardiology, Warsaw, Poland. The trial plans to enroll 300 participants.