Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha PCD-CT Before TAVI Procedure (Alpha Registry)

Semmelweis University

Status: Enrolling

Conditions: Coronary Artery Disease; Aortic Valve Stenosis; Tomography, X-Ray Computed

Treatments: Diagnostic Test: Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07016477

BM/9095-1/2024

Details and patient eligibility

About

The clinical and demographic characteristics of patients undergoing transcatheter aortic valve implantation (TAVI) pose unique challenges for coronary computed tomography (CT) imaging, as this patient population is mainly composed of elderly, frail individuals with severe aortic stenosis, multiple comorbidities, high prevalence of heavily calcified coronary artery disease (CAD) and revascularized coronary arteries. Such vulnerable patients could benefit from a more precise assessment and characterization of their CAD with ultra-high resolution (UHR) photon-counting detector (PCD) CT that would potentially avoid the need for pre-implantation invasive coronary angiography (ICA). This international multicenter prospective registry study aims to investigate the feasibility and diagnostic accuracy of PCD-CT in the assessment of CAD in the high-risk population of patients undergoing TAVI, as compared to ICA.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically indicated TAVI
• Clinically indicated CT and invasive coronary angiography
• There are no contraindications to CT angiography.
• Understanding and signing the consent form

Exclusion criteria

• Pregnancy or breastfeeding
• Chronic renal failure (eGFR <30 ml/m2)
• Active oncological treatment
• Any condition for which TAVI is contraindicated and therefore no prior radiological investigation of TAVI is indicated

Trial design

1,000 participants in 1 patient group

Aortic stenosis

Description:

Patients with aortic valve disease for whom transcatheter aortic valve implantation is indicated and who present for pre-interventional evaluation will be enrolled after written consent.

Treatment:

Diagnostic Test: Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography