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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSemmelweis University

About this trial

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

Qualifiers

Clinically indicated TAVI

Clinically indicated CT and invasive coronary angiography

There are no contraindications to CT angiography.

Understanding and signing the consent form

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

1,000 Participants
are divided into 1 treatment group

Sponsors and collaborators

Semmelweis University

Lead sponsor

Siemens Corporation, Corporate Technology

Collaborator