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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha PCD-CT Before TAVI Procedure
At a glance
Conditions
Where it's being run
7 sites across 5 statesStudy leadership
- Pál Maurovich-Horvat, MD, PhD, DSc · PRINCIPAL_INVESTIGATOR · Semmelweis University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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