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

NCT ID: NCT07016477

Last Updated: 2025-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2030-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease Aortic Valve Stenosis Tomography, X-Ray Computed

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Aortic stenosis

Patients with aortic valve disease for whom transcatheter aortic valve implantation is indicated and who present for pre-interventional evaluation will be enrolled after written consent.

Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Photon-Counting Detector CT (Naeotom Alpha, Siemens Healthineers)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Siemens Corporation, Corporate Technology

INDUSTRY

Sponsor Role collaborator

Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

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Prof. Maurovich-Horvat Pál

PhD, MPH, DSc, Director of Medical Imaging Centre, Chairman of Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pál Maurovich-Horvat, MD, PhD, DSc

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status RECRUITING

Albert-Ludwigs-Universität Freiburg

Freiburg im Breisgau, , Germany

Site Status NOT_YET_RECRUITING

University Medical Center Mainz

Mainz, , Germany

Site Status RECRUITING

Universitätsklinikum Tübingen

Tübingen, , Germany

Site Status NOT_YET_RECRUITING

Semmelweis University

Budapest, , Hungary

Site Status RECRUITING

Maastricht University

Maastricht, , Netherlands

Site Status NOT_YET_RECRUITING

University Hospital of Zürich

Zurich, , Switzerland

Site Status NOT_YET_RECRUITING

Countries

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United States Germany Hungary Netherlands Switzerland

Central Contacts

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Pál Maurovich-Horvat, MD, PhD, DSc

Role: CONTACT

+3614591500 ext. 61628

Facility Contacts

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Akos Varga-Szemes, MD, PhD

Role: primary

+1843-876-7146

Fabian Bamberg, MD

Role: primary

0049-761-270-38050

Tilman Emrich, MD

Role: primary

+49613117 ext. 7358

Konstantin Nikolaou, MD

Role: primary

07071 29-82087

Pál Maurovich-Horvat, MD, PhD, DSc

Role: primary

+36 1 459 1500 ext. 61661

Joachim Wildberger, MD

Role: primary

+31(0)43 387 49 12

Hatem Alkadhi, MD

Role: primary

+41 44 255 36 62

Other Identifiers

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BM/9095-1/2024

Identifier Type: -

Identifier Source: org_study_id

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