Ultra-high-resolution cardiac CT with NAEOTOM Alpha before TAVI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting
• University Medical Center Mainz
  Mainz, Germany Recruiting
• Semmelweis University
  Budapest, Hungary Recruiting
• Albert-Ludwigs-Universität Freiburg
  Freiburg im Breisgau, Germany Not yet recruiting
• Universitätsklinikum Tübingen
  Tübingen, Germany Not yet recruiting
• Maastricht University
  Maastricht, Netherlands 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.