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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: The Echo-CA score Study is an investigator-initiated, prospective, multicenter study of consecutive patients undergoing clinically indicated standard transthoracic echocardiography and cardiac CT with available calcium score performed within 3 months. The study population is expected to include approximately 50% patients with severe AS and 50% without severe AS, in order to ensure a balanced case-control distribution and optimize the precision of diagnostic performance estimates. All patients will be managed according to current standards of care. Clinical evaluation will include systematic collection of cardiovascular risk factors, comorbidities, medical therapy, and detailed symptom assessment (angina, syncope, dyspnea), as well as NYHA functional class. Each participant will undergo: i) comprehensive transthoracic echocardiography (TTE) performed according to current ESC Guideline; ii) cardiac CT with aortic valve calcium quantification, performed according to contemporary acquisiti

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Conditions

Aortic Stenosis, Chronic Coronary Syndrome, Calcific Aortic Valve Disease, Calcific Aortic Stenosis

Being tested

Echocardiography and Cardiac CT

Keywords

Aortic stenosis, Low-flow, Aortic valve calcium score, Echocardiography, Cardiac-CT

Medical subject headings

Aortic Valve Stenosis, Aortic Valve, Calcification of

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Echocardiography and Cardiac CTDiagnostic test

  This is a non-interventional, observational study in which all patients will undergo clinically indicated standard-of-care transthoracic echocardiography (TTE) and cardiac computed tomography (CT) with aortic valve calcium scoring. No investigational drug, device, or additional invasive procedure will be administered as part of the study. Echocardiographic images acquired during routine clinical practice will be anonymized and centrally analyzed using dedicated artificial intelligence-based software to derive and validate the echocardiographic aortic valve calcium score. Patient management, follow-up, and therapeutic decisions, including referral for aortic valve replacement, will remain entirely at the discretion of the treating physicians according to current clinical guidelines and standard practice.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Derivation of Echo-AVCS

   To derive an echocardiographic aortic valve calcium score (Echo-AVCS) for confirming severe aortic stenosis (AS), using CT-derived aortic valve calcium as the reference standard.

   Measured: 6 months

2. Validation of Echo-AVCS

   To validate an echocardiographic aortic valve calcium score (Echo-AVCS) for confirming severe aortic stenosis (AS), using CT-derived aortic valve calcium as the reference standard.

   Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted2 Jun 2026
2. Study start1 Mar 2026
3. Primary completion31 Dec 2026 (estimated)
4. Study completion31 Dec 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Aortic StenosisStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.