Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha PCD-CT Before TAVI Procedure
Recruiting now
Conditions studied: Coronary Artery Disease, Aortic Valve Stenosis, Tomography, X-Ray Computed
In brief
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.
Key facts
- Study ID
- NCT07016477
- Run by
- Semmelweis University
- People needed
- 1000
- Starts
- 2024-06-01
- Expected to finish
- 2030-05-30
- Last updated by the study team
- 2025-06-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Clinically indicated TAVI
- Clinically indicated CT and invasive coronary angiography
- There are no contraindications to CT angiography.
- Understanding and signing the consent form
You may not qualify if…
- 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
Where it is running
- Semmelweis University — Budapest, Hungary (enrolling)
- University Medical Center Mainz — Mainz, Germany (enrolling)
- Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
- University Hospital of Zürich — Zurich, Switzerland
- Universitätsklinikum Tübingen — Tübingen, Germany
- Albert-Ludwigs-Universität Freiburg — Freiburg im Breisgau, Germany
- Maastricht University — Maastricht, Netherlands
Full record on ClinicalTrials.gov
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