Ultra-high-resolution cardiac CT with NAEOTOM Alpha before TAVI
Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha Photon Counting-detector CT Before Transcatheter Aortic Valve Implantation
This study will test whether ultra-high-resolution photon-counting CT can accurately detect coronary artery disease in patients having TAVI and potentially reduce the need for invasive coronary angiography.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Semmelweis University Academic / other |
| Locations | 7 sites (Charleston, South Carolina and 6 other locations) |
| Trial ID | NCT07016477 on ClinicalTrials.gov |
What this trial studies
This is an international, prospective multicenter registry enrolling patients scheduled for transcatheter aortic valve implantation who are also undergoing clinically indicated coronary CT and invasive coronary angiography. Participants receive ultra-high-resolution photon-counting detector (PCD) coronary CT with the NAEOTOM Alpha prior to TAVI, and imaging results are compared to invasive coronary angiography to determine feasibility and diagnostic accuracy. The registry captures clinical and demographic factors, image quality metrics, and concordance with invasive angiography across multiple centers. Key exclusions include severe renal impairment, pregnancy, active oncologic treatment, or any condition that contraindicates TAVI or CT angiography.
Who should consider this trial
Good fit: Ideal candidates are patients planned for TAVI who can undergo both CT angiography and invasive coronary angiography, have acceptable kidney function (eGFR ≥30 ml/min/1.73m2), and can provide informed consent.
Not a fit: Patients with severe chronic renal failure, those who are pregnant or breastfeeding, on active oncologic treatment, or those for whom TAVI or CT angiography is contraindicated are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could give frail TAVI patients more precise noninvasive coronary imaging and reduce the need for invasive angiography.
How similar studies have performed: Conventional CT coronary angiography has shown diagnostic utility in some TAVI populations, but ultra-high-resolution photon-counting CT is relatively new and currently supported mainly by limited pilot and technical studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Charleston, South Carolina and 6 other locations
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- Albert-Ludwigs-Universität Freiburg — Freiburg im Breisgau, Germany (Not_yet_recruiting)
- University Medical Center Mainz — Mainz, Germany (Recruiting)
- Universitätsklinikum Tübingen — Tübingen, Germany (Not_yet_recruiting)
- Semmelweis University — Budapest, Hungary (Recruiting)
- Maastricht University — Maastricht, Netherlands (Not_yet_recruiting)
- University Hospital of Zürich — Zurich, Switzerland (Not_yet_recruiting)
Study contacts
- Principal investigator: Pál Maurovich-Horvat, MD, PhD, DSc — Semmelweis University
- Study coordinator: Pál Maurovich-Horvat, MD, PhD, DSc
- Email: maurovich-horvat.pal@semmelweis.hu
- Phone: +3614591500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.