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Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha PCD-CT Before TAVI Procedure
Sponsor: Semmelweis University
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.
Official title: Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha Photon Counting-detector CT Before Transcatheter Aortic Valve Implantation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2024-06-01
Completion Date
2030-05-30
Last Updated
2025-06-11
Healthy Volunteers
No
Interventions
Ultra-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.
Locations (7)
Medical University of South Carolina
Charleston, South Carolina, United States
Albert-Ludwigs-Universität Freiburg
Freiburg im Breisgau, Germany
University Medical Center Mainz
Mainz, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Semmelweis University
Budapest, Hungary
Maastricht University
Maastricht, Netherlands
University Hospital of Zürich
Zurich, Switzerland