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

Last updated: June 4, 2025
Sponsor: Semmelweis University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Thrombosis

Hypercholesterolemia

Treatment

Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography

Clinical Study ID

NCT07016477
BM/9095-1/2024
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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

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 radiologicalinvestigation of TAVI is indicated

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography
Phase:
Study Start date:
June 01, 2024
Estimated Completion Date:
May 30, 2030

Connect with a study center

  • Albert-Ludwigs-Universität Freiburg

    Freiburg, 79098
    Germany

    Site Not Available

  • University Medical Center Mainz

    Mainz, 55116
    Germany

    Active - Recruiting

  • Universitätsklinikum Tübingen

    Tübingen, 2669
    Germany

    Site Not Available

  • Semmelweis University

    Budapest,
    Hungary

    Active - Recruiting

  • Maastricht University

    Maastricht, 6211
    Netherlands

    Site Not Available

  • University Hospital of Zürich

    Zürich, 8091
    Switzerland

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.