Clinical trial NCT07016477: Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha PCD-CT Before TAVI Procedure
Official title: Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha Photon Counting-detector CT Before Transcatheter Aortic Valve Implantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Aortic Valve Stenosis
Tomography, X-Ray Computed
Keywords: photon-counting detector computed tomography
Lead sponsor: Semmelweis University
Sponsor class: OTHER
Collaborators: name: Siemens Corporation, Corporate Technology
First posted: 2025-06-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients with aortic valve stenosis for whom TAVI is indicated and who present for pre-operative investigation.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic Accuracy of Ultra-High Resolution Photon-Counting Detector Coronary Computed Tomography Angiography (UHR PCD-CT CCTA)
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Image Noise Analysis Across Reconstruction Parameters
timeFrame: through study completion, an average of 2 years
measure: Correlation of Image Noise and Body Mass Index
timeFrame: through study completion, an average of 2 years
measure: Correlation of Image Noise and Heart Rate
timeFrame: through study completion, an average of 2 years
measure: Contrast-to-Noise Ratio (CNR) Analysis Across Reconstruction Parameters
timeFrame: through study completion, an average of 2 years
measure: Vessel Sharpness Analysis Across Reconstruction Parameters
timeFrame: through study completion, an average of 2 years
measure: Blooming Analysis Across Reconstruction Parameters
timeFrame: through study completion, an average of 2 years
measure: Subjective Image Quality Analysis
timeFrame: through study completion, an average of 2 years
measure: Correlation of Quantitative Coronary Artery Disease Assessment
timeFrame: through study completion, an average of 2 years
measure: Correlation of Quantitative In-Stent Restenosis Assessment
timeFrame: through study completion, an average of 2 years
measure: Correlation of Fractional Flow Reserve Measurement
timeFrame: through study completion, an average of 2 years
measure: Quantitative Assessment of Plaque Composition
timeFrame: through study completion, an average of 2 years
measure: Correlation of Plaque Composition
timeFrame: through study completion, an average of 2 years
measure: Quantitative Assessment of Extracellular Volume Fraction
timeFrame: through study completion, an average of 2 years
measure: Analysis of Structured Coronary Artery Disease Reporting in UHR PCD-CT
timeFrame: through study completion, an average of 2 years
measure: Correlation of Quantitative UHR PCD-CT CCTA Parameters with Ischemia Imaging Tests
timeFrame: through study completion, an average of 2 years
measure: Correlation of Quantitative UHR PCD-CT CCTA Parameters with Other Imaging Tests
timeFrame: through study completion, an average of 2 years
measure: Correlation Between PCAT Attenuation and CT-derieved or Clinical Parameters
timeFrame: from inclusion up to a maximum follow-up period of 5 years
measure: Correlation Between EAT Attenuation and CT-derieved or Clinical Parameters
timeFrame: from inclusion up to a maximum follow-up period of 5 years
measure: Lung Water Density Quantification
timeFrame: through study completion, an average of 2 years
measure: Assessment of Whole Body Extracellular Volume
timeFrame: through study completion, an average of 2 years
measure: Major Adverse Cardiac Events
timeFrame: from inclusion up to a maximum follow-up period of 5 years
measure: Extended Major Adverse Cardiovascular Events
timeFrame: from inclusion up to a maximum follow-up period of 5 years
measure: Prosthesis Function Evaluation
timeFrame: from inclusion up to a maximum follow-up period of 5 years
measure: Cost-effectiveness
timeFrame: from inclusion up to a maximum follow-up period of 5 years
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Freiburg
country: Germany
facility: Albert-Ludwigs-Universität Freiburg
city: Mainz
country: Germany
facility: University Medical Center Mainz
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Budapest
country: Hungary
facility: Semmelweis University
city: Maastricht
country: Netherlands
facility: Maastricht University
city: Zürich
country: Switzerland
facility: University Hospital of Zürich
Study officials:
affiliation: Semmelweis University
name: Pál Maurovich-Horvat, MD, PhD, DSc
role: PRINCIPAL_INVESTIGATOR
References: