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

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Semmelweis University
Study ID
NCT07016477
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 1, 2024
Status verified
Jun 2025
Primary completion
May 30, 2029
Completion
May 30, 2030

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Aortic stenosis
    Patients with aortic valve disease for whom transcatheter aortic valve implantation is indicated and who present for pre-interventional evaluation will be enrolled after written consent.

Primary Outcome Measure

Diagnostic Accuracy of Ultra-High Resolution Photon-Counting Detector Coronary Computed Tomography Angiography (UHR PCD-CT CCTA) [ Time Frame: through study completion, an average of 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
Akos Varga-Szemes, MD, PhD
[email protected]
+1843-876-7146
U. Joseph Schoepf, MD (PRINCIPAL_INVESTIGATOR)
Akos Varga-Szemes, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Medical University of South Carolina· Charleston, SC

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