🏛️ Verified NIH Record • Updated 2025-06-04

Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha PCD-CT Before TAVI Procedure (NCT07016477)

Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha Photon Counting-detector CT Before Transcatheter Aortic Valve Implantation

🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Semmelweis University

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Medical University of South Carolina — Charleston, South Carolina

Age range: 18 Years

🧪 Interventions in This Study

  • Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography (DIAGNOSTIC_TEST)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (7 Sites)

  • Medical University of South Carolina — Charleston, South Carolina
  • Albert-Ludwigs-Universität Freiburg — Freiburg im Breisgau,
  • University Medical Center Mainz — Mainz,
  • Universitätsklinikum Tübingen — Tübingen,
  • Semmelweis University — Budapest,
  • Maastricht University — Maastricht,
  • University Hospital of Zürich — Zurich,

📞 Contact the Study Coordinator

Phone: (361) 459-1500

Email: maurovich-horvat.pal@semmelweis.hu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗