NCT07016477 Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha PCD-CT Before TAVI Procedure
| NCT ID | NCT07016477 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Semmelweis University |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2029-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2024-06-01 with a primary completion date of 2029-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Pál Maurovich-Horvat, MD, PhD, DSc
PRINCIPAL INVESTIGATOR
Semmelweis University
Frequently Asked Questions
Who can join the NCT07016477 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07016477 currently recruiting?
Yes, NCT07016477 is actively recruiting participants. Contact the research team at maurovich-horvat.pal@semmelweis.hu for enrollment information.
Where is the NCT07016477 trial being conducted?
This trial is being conducted at Charleston, United States, Freiburg im Breisgau, Germany, Mainz, Germany, Tübingen, Germany and 3 additional locations.
Who is sponsoring the NCT07016477 clinical trial?
NCT07016477 is sponsored by Semmelweis University. The principal investigator is Pál Maurovich-Horvat, MD, PhD, DSc at Semmelweis University. The trial plans to enroll 1,000 participants.