NCT07620925 Derivation and Validation of the Aortic Valve Echocardiographic Calcium Score to Confirm Severe Aortic Stenosis: the Echo-AVCS Study

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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 250 participants in total. It began in 2026-03-01 with a primary completion date of 2026-12-31.

Brief Summary

The Echo-AVCS Study is an investigator-initiated, prospective, multicenter observational study designed to derive and validate an artificial intelligence (AI)-based echocardiographic aortic valve calcium score (Echo-AVCS) for confirming severe aortic stenosis (AS). Transthoracic echocardiography (TTE) is the standard imaging modality for assessing AS severity; however, discrepancies between valve area and transvalvular gradient measurements may complicate diagnosis, particularly in low-flow or discordant AS presentations. Cardiac computed tomography (CT)-derived aortic valve calcium scoring is currently used to resolve diagnostic uncertainty, but it involves additional cost and radiation exposure. This study will enroll consecutive adult patients undergoing clinically indicated TTE and cardiac CT with calcium scoring performed within 3 months. Standardized echocardiographic images will be centrally analyzed using dedicated AI-based image segmentation and machine learning methods to quantify aortic valve calcification directly from TTE images. CT-derived aortic valve calcium score will serve as the reference standard. The primary objective is to derive and validate the Echo-AVCS score for identifying severe AS. Secondary objectives include determination of sex-specific diagnostic thresholds, correlation with CT calcium volume, association with symptoms and NYHA class, and evaluation of prognostic associations with aortic valve replacement, heart failure hospitalization, cardiovascular events, and mortality at 1-year follow-up.

Eligibility Criteria

Inclusion Criteria: * Age \> 18 years old * Clinical indication for standard transthoracic echocardiography. * Clinical indication for cardiac CT with available calcium score. * 3-month time interval between transthoracic echocardiography and cardiac CT. * Able to give informed consent. Exclusion Criteria: * Patients with inadequate transthoracic echocardiographic images. * Poor quality cardiac CT, inadequate for standard calcium score assessment. * Patients with known prior stents and/or coronary artery bypass grafts. * Patients with known previous percutaneous or surgical aortic valve replacement. * Patients with active or a history of endocarditis. * Patients with congenital heart defects (other than isolated bicuspid aortic valve).

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