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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography (diagnostic test)
Sponsor: Semmelweis University · Participants: 1,000 · Started: Jun 1, 2024
Contact the study team
- Pál Maurovich-Horvat, MD, PhD, DSc · Phone: +3614591500
Official record on ClinicalTrials.gov — NCT07016477
Locations in the U.S.
| South Carolina | Medical University of South Carolina, Charleston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.