|

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

RECRUITINGSponsored by Semmelweis University
Actively Recruiting
SponsorSemmelweis University
Started2024-06-01
Est. completion2029-05-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions4

Aortic Valve StenosisCoronary Artery DiseaseHeart DiseaseTomography, X-Ray Computed

Locations1 site

Medical University of South Carolina
Charleston, South Carolina, 29425
Akos Varga-Szemes, MD, PhD+1843-876-7146vargaasz@musc.edu

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.