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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 PCD-CT Before TAVI Procedure

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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

Study details
    Coronary Artery Disease
    Aortic Valve Stenosis
    Tomography
    X-Ray Computed

NCT07016477

Semmelweis University

15 October 2025

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