Menu
Recruiting NCT07016477

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Aortic Valve Stenosis, Tomography, X-Ray Computed. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Germany, Hungary, Netherlands, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha Photon Counting-detector CT Before Transcatheter Aortic Valve Implantation

Overview

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.

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.

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Image Noise Analysis Across Reconstruction Parameters [Time frame: through study completion, an average of 2 years]
  • Correlation of Image Noise and Body Mass Index [Time frame: through study completion, an average of 2 years]
  • Correlation of Image Noise and Heart Rate [Time frame: through study completion, an average of 2 years]
  • Contrast-to-Noise Ratio (CNR) Analysis Across Reconstruction Parameters [Time frame: through study completion, an average of 2 years]
  • Vessel Sharpness Analysis Across Reconstruction Parameters [Time frame: through study completion, an average of 2 years]
  • Blooming Analysis Across Reconstruction Parameters [Time frame: through study completion, an average of 2 years]
  • Subjective Image Quality Analysis [Time frame: through study completion, an average of 2 years]
  • Correlation of Quantitative Coronary Artery Disease Assessment [Time frame: through study completion, an average of 2 years]
  • Correlation of Quantitative In-Stent Restenosis Assessment [Time frame: through study completion, an average of 2 years]
  • Correlation of Fractional Flow Reserve Measurement [Time frame: through study completion, an average of 2 years]
  • Quantitative Assessment of Plaque Composition [Time frame: through study completion, an average of 2 years]
  • Correlation of Plaque Composition [Time frame: through study completion, an average of 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 3 centers
  • Albert-Ludwigs-Universität Freiburg — Freiburg im Breisgau
  • University Medical Center Mainz — Mainz
  • Universitätsklinikum Tübingen — Tübingen
United States · 1 center
  • Medical University of South Carolina — Charleston
Hungary · 1 center
  • Semmelweis University — Budapest
Netherlands · 1 center
  • Maastricht University — Maastricht
Switzerland · 1 center
  • University Hospital of Zürich — Zurich

Identifiers

NCT: NCT07016477 · BM/9095-1/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗