Actively Recruiting

Age: 18Years +
All Genders
NCT07016477

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

Led by Semmelweis University · Updated on 2025-06-11

1000

Participants Needed

7

Research Sites

312 weeks

Total Duration

On this page

Sponsors

S

Semmelweis University

Lead Sponsor

S

Siemens Corporation, Corporate Technology

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinically indicated transcatheter aortic valve implantation (TAVI)
  • Clinically indicated CT and invasive coronary angiography
  • No contraindications to CT angiography
  • Ability to understand and sign the consent form
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Chronic renal failure with eGFR less than 30 ml/m2
  • Active oncological treatment
  • Any condition that contraindicates TAVI and prior radiological investigation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

2

Albert-Ludwigs-Universität Freiburg

Freiburg im Breisgau, Germany, 79098

Not Yet Recruiting

3

University Medical Center Mainz

Mainz, Germany, 55116

Actively Recruiting

4

Universitätsklinikum Tübingen

Tübingen, Germany, 2669

Not Yet Recruiting

5

Semmelweis University

Budapest, Hungary

Actively Recruiting

6

Maastricht University

Maastricht, Netherlands, 6211

Not Yet Recruiting

7

University Hospital of Zürich

Zurich, Switzerland, 8091

Not Yet Recruiting

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Research Team

P

Pál Maurovich-Horvat, MD, PhD, DSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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