Back to Trials
NCT07016477Recruiting

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

Semmelweis University

Start Date

6/1/2024

Completion Date

5/30/2030

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

Age Range: 18 years to No maximum

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

Interventions

DIAGNOSTIC_TEST

Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Coronary Artery DiseaseAortic Valve StenosisTomography, X-Ray Computed

Locations

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Albert-Ludwigs-Universität Freiburg

Freiburg im Breisgau, 79098

Germany

University Medical Center Mainz

Mainz, 55116

Germany

Universitätsklinikum Tübingen

Tübingen, 2669

Germany

Semmelweis University

Budapest,

Hungary

Maastricht University

Maastricht, 6211

Netherlands

University Hospital of Zürich

Zurich, 8091

Switzerland