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

NCT07016477 | Recruiting

• 1 other identifier: BM/9095-1/2024
• Study Type: observational
• Target: 1,000
• Locations: 5 countries
• Sites: 7

Brief 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

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

Keywords

photon-counting detector computed tomography

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of Ultra-High Resolution Photon-Counting Detector Coronary Computed Tomography Angiography (UHR PCD-CT CCTA)

  Assessment of the diagnostic accuracy (sensitivity, specificity, PPV, NPV) of UHR PCD-CT coronary angiography as compared to invasive coronary angiography (ICA) within three months of PCD-CT

  through study completion, an average of 2 years

Secondary Outcomes (24)

• Image Noise Analysis Across Reconstruction Parameters

  through study completion, an average of 2 years

• Correlation of Image Noise and Body Mass Index

  through study completion, an average of 2 years

• Correlation of Image Noise and Heart Rate

  through study completion, an average of 2 years

• Contrast-to-Noise Ratio (CNR) Analysis Across Reconstruction Parameters

  through study completion, an average of 2 years

• Vessel Sharpness Analysis Across Reconstruction Parameters

  through study completion, an average of 2 years

Study Arms (1)

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.

Diagnostic Test: Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography

Interventions

Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography 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.

Also known as: Photon-Counting Detector CT (Naeotom Alpha, Siemens Healthineers)

Aortic stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients with aortic valve stenosis for whom TAVI is indicated and who present for pre-operative investigation.

You may qualify if:

• Clinically indicated TAVI
• Clinically indicated CT and invasive coronary angiography
• There are no contraindications to CT angiography.
• Understanding and signing the consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Semmelweis University: lead
• Siemens Corporation, Corporate Technology: collaborator

Study Sites (7)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Albert-Ludwigs-Universität Freiburg

Freiburg im Breisgau, 79098, Germany

NOT YET RECRUITING

University Medical Center Mainz

Mainz, 55116, Germany

RECRUITING

Universitätsklinikum Tübingen

Tübingen, 2669, Germany

NOT YET RECRUITING

Semmelweis University

Budapest, Hungary

RECRUITING

Maastricht University

Maastricht, 6211, Netherlands

NOT YET RECRUITING

University Hospital of Zürich

Zurich, 8091, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Study Officials

• Pál Maurovich-Horvat, MD, PhD, DSc

  Semmelweis University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pál Maurovich-Horvat, MD, PhD, DSc

CONTACT

+3614591500; maurovich-horvat.pal@semmelweis.hu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MPH, DSc, Director of Medical Imaging Centre, Chairman of Radiology

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: June 11, 2025
• Study Start: June 1, 2024
• Primary Completion (Estimated): May 30, 2029
• Study Completion (Estimated): May 30, 2030
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

NL (1); DE (3); HU (1); CH (1); US (1)