Observational Study of NAEOTOM Alpha PCD-CT Before TAVI

This study is looking at a special type of CT scan called Ultra-High Resolution Photon-Counting Detector Coronary Computed Tomography Angiography (UHR PCD-CT CCTA) for people who are going to have a TAVI (transcatheter aortic valve implantation) procedure. TAVI is a way to replace a heart valve without open-heart surgery. The study wants to see how accurate this new CT scan is at looking at your coronary arteries (the blood vessels that supply your heart). This is important because many TAVI patients are older and may have hardened arteries, which can be hard to see clearly with regular CT scans. The goal is to see if this advanced CT scan can provide a clearer picture, potentially avoiding the need for a more invasive procedure called coronary angiography before TAVI. This is an observational study, meaning researchers will collect information from your routine care. We are looking to enroll 1000 participants. The study status is currently unclear.

Study design
This is an observational study, meaning researchers will collect information from your routine care. It aims to enroll 1000 participants.
What's involved
You would undergo a clinically indicated Ultra-High Resolution Photon-Counting Detector Coronary Computed Tomography Angiography (UHR PCD-CT CCTA) as part of your pre-TAVI evaluation. You will be followed through study completion, which is an average of 2 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, which is an average of 2 years.

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NCT07016477

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

Recruiting
Not specifiedAges 18+Observational
Semmelweis University
~1,000 participants
Updated 2025-06-11 on ClinicalTrials.gov
What's tested:Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography

At a glance

Recruiting sites
3 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diagnostic Accuracy of Ultra-High Resolution Photon-Counting Detector Coronary Computed Tomography Angiography (UHR PCD-CT CCTA)
Measured over through study completion, an average of 2 years
Coronary Artery Disease
Aortic Valve Stenosis
Tomography, X-Ray Computed
7 sites across 5 states
Germany3
South Carolina1
Hungary1
Netherlands1
Switzerland1
  • Pál Maurovich-Horvat, MD, PhD, DSc · PRINCIPAL_INVESTIGATOR · Semmelweis University

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Clinically indicated TAVI
Clinically indicated CT and invasive coronary angiography
There are no contraindications to CT angiography.
Understanding and signing the consent form

Exclusion

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

    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