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

NCT07016477 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-06-11

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography

Clinically indicated Ultra-High Resolution Photon-Counting Detector Coronary Computed Tomography Angiography (UHR PCD-CT CCTA) for the pre-procedural evaluation of patients scheduled to undergo transcatheter aortic valve implantation.

Sponsors & Collaborators

  • Siemens Corporation, Corporate Technology

    collaborator INDUSTRY

  • Semmelweis University

    lead OTHER

Principal Investigators

  • Pál Maurovich-Horvat, MD, PhD, DSc · Semmelweis University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2029-05-30
Completion
2030-05-30

Countries

  • United States
  • Germany
  • Hungary
  • Netherlands
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07016477 on ClinicalTrials.gov