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Search / Trial NCT07016477

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

Launched by SEMMELWEIS UNIVERSITY · Jun 4, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Photon Counting Detector Computed Tomography

ClinConnect Summary

This clinical trial is looking at a new type of imaging called ultra-high resolution photon-counting detector computed tomography (PCD-CT) to better evaluate patients who are scheduled to have a transcatheter aortic valve implantation (TAVI). TAVI is a procedure used to replace a narrowed valve in the heart, and the patients involved in this study often have complex health issues, including severe heart valve problems and other conditions that make traditional imaging techniques challenging. The goal of the study is to see if PCD-CT can provide a clearer picture of the heart's blood vessels, which could help avoid the need for more invasive procedures like coronary angiography.

To be eligible for this trial, participants must be planning to have TAVI and require a CT scan and a coronary angiogram. They should not have any conditions that would prevent them from safely undergoing a CT scan, and they need to be able to understand and sign a consent form. Unfortunately, people who are pregnant, have severe kidney problems, are undergoing active cancer treatment, or have other specific health issues cannot take part. Participants in the study can expect to undergo imaging tests and will be monitored to see how well the new CT technology works for assessing their heart conditions.

Gender

ALL

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

About Semmelweis University

Semmelweis University, located in Budapest, Hungary, is a prestigious institution renowned for its commitment to advancing medical education, research, and healthcare innovation. As a prominent clinical trial sponsor, the university leverages its extensive expertise in various medical fields to conduct rigorous clinical studies aimed at improving patient outcomes and enhancing therapeutic strategies. With a focus on ethical standards and scientific excellence, Semmelweis University collaborates with a network of healthcare professionals and researchers to translate groundbreaking discoveries into practical applications, ultimately contributing to the global advancement of medical science.

Locations

Charleston, South Carolina, United States

Budapest, , Hungary

Zürich, , Switzerland

Freiburg, , Germany

Mainz, , Germany

Tübingen, , Germany

Maastricht, , Netherlands

Patients applied

0 patients applied

Trial Officials

Pál Maurovich-Horvat, MD, PhD, DSc

Principal Investigator

Semmelweis University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported