RecruitingNCT07016477

Alpha Registry

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

Semmelweis UniversityOne US siteView on ClinicalTrials.gov

AI Description

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.

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Who can join
adult, older adult
Participants
1000
Expected completion
2030-05-30
Funded by
other

Conditions studied

Aortic Valve Stenosis, Coronary Artery Disease, Tomography, X-Ray Computed

What is being tested

  • DIAGNOSTIC_TEST: Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography

What it measures

  • Diagnostic Accuracy of Ultra-High Resolution Photon-Counting Detector Coronary Computed Tomography Angiography (UHR PCD-CT CCTA), Assessment of the diagnostic accuracy (sensitivity, specificity, PPV, NPV) of UHR PCD-CT coronary angiography as compared to invasive coronary angiography (ICA) within three months of PCD-CT, through study completion, an average of 2 years

Working with

Siemens Corporation, Corporate Technology

Centers Participating

These centers are participating in this study. Reach out to them directly to learn more.

Data Sources and Methodology

Registry entry updated 2025-06-11

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