AI Assessment of Low-Gradient Aortic Stenosis Severity Based on Echocardiography
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational Institute of Cardiology, Warsaw, Poland
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Clinical suspicion of significant low-gradient aortic stenosis
Echocardiographic examination performed for clinical indications
Ability to provide informed consent
Disqualifiers
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
Trial population
The study population will include adult patients (≥18 years) diagnosed in the Echocardiography Laboratory of the National Institute of Cardiology in Warsaw, Department of Valvular Heart Disease. Eligible participants will be those referred for echocardiographic evaluation due to clinical suspicion of significant low-gradient aortic stenosis. Standard-of-care imaging performed for clinical indications will be analyzed. Approximately 300 patients are expected to be enrolled between 2025 and 2026. Patients with previous aortic valve intervention (surgical or transcatheter) or other exclusion criteria will not be included.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
AI diagnostic test for severe low-gradient aortic stenosis
Diagnostic testAll 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.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Patients with suspected significant low-gradient aortic stenosis.1 intervention
Trial outcomes
Primary outcomes
1
Area Under the Receiver Operating Characteristic Curve (AUC) describing the sensitivity-specificity relationship of the AI model.
AUC will be calculated to assess the ability of the AI model to differentiate between severe low-gradient and moderate aortic stenosis. The analysis will use physician assessment and guideline-based diagnostic criteria as the reference standard. AUC will be reported with 95% confidence intervals.
Time frame
At the time of the nearest Heart Team meeting following the echocardiographic examination (typically within 1 week).Secondary outcomes
1
Diagnostic performance of the AI model in clinically relevant subgroups.
Diagnostic performance of the AI model (AUC, sensitivity, specificity) in clinically relevant subgroups, such as patients with atrial fibrillation or subtypes of low-gradient aortic stenosis (classic, paradoxical, normal flow).
Time frame
At the nearest Heart Team meeting following the echocardiographic examination (typically within 1 week).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National Institute of Cardiology, Warsaw, Poland
Lead sponsor
The Institute of Bioorganic Chemistry, Polish Academy of Sciences
Collaborator
Source ClinicalTrials.gov