RecruitingNCT07016477

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

Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha Photon Counting-detector CT Before Transcatheter Aortic Valve Implantation

Sponsor

Semmelweis University

Enrollment

1,000 participants

Start Date

Jun 1, 2024

Study Type

OBSERVATIONAL

Conditions

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

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria4

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

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Interventions

DIAGNOSTIC_TESTUltra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography

Clinically indicated Ultra-High Resolution Photon-Counting Detector Coronary Computed Tomography Angiography (UHR PCD-CT CCTA) for the pre-procedural evaluation of patients scheduled to undergo transcatheter aortic valve implantation.