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RECRUITING
NCT07016477

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

Sponsor: Semmelweis University

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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