RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha Photon Counting-detector CT Before Transcatheter Aortic Valve Implantation

Quick Facts

Study Start:2024-06-01
Study Completion:2030-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07016477

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Clinically indicated TAVI
  2. * Clinically indicated CT and invasive coronary angiography
  3. * There are no contraindications to CT angiography.
  4. * Understanding and signing the consent form
  1. * Pregnancy or breastfeeding
  2. * Chronic renal failure (eGFR \<30 ml/m2)
  3. * Active oncological treatment
  4. * Any condition for which TAVI is contraindicated and therefore no prior radiological investigation of TAVI is indicated

Contacts and Locations

Study Contact

Pál Maurovich-Horvat, MD, PhD, DSc
CONTACT
+3614591500
maurovich-horvat.pal@semmelweis.hu

Principal Investigator

Pál Maurovich-Horvat, MD, PhD, DSc
PRINCIPAL_INVESTIGATOR
Semmelweis University

Study Locations (Sites)

Medical University of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Semmelweis University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-01
Study Completion Date2030-05-30

Study Record Updates

Study Start Date2024-06-01
Study Completion Date2030-05-30

Terms related to this study

Keywords Provided by Researchers

  • photon-counting detector computed tomography

Additional Relevant MeSH Terms

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