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Search / Trial NCT05075590

Coronary Access After Supra-Annular THV Implantation

Launched by UNIVERSITY OF BRITISH COLUMBIA · Oct 7, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Elective Transfemoral Tavr Evolut Valve Supra Annular Transcatheter Heart Valve Commissural Alignment Coronary Angiography Transcatheter Aortic Valve Replacement Coronary Access

ClinConnect Summary

This clinical trial, titled "Coronary Access After Supra-Annular THV Implantation," is looking to find the best way to access the coronary arteries after a specific heart procedure called Transcatheter Aortic Valve Replacement (TAVR) using a device known as the Evolut THV. The goal is to figure out the most effective techniques and tools for doctors to use during and after this procedure, especially when aligning the device correctly.

To participate in this study, you must be between 65 and 74 years old and scheduled for an elective TAVR with the Evolut THV. It's important that you can provide written consent to join the study. However, if you have certain health conditions, like severe kidney disease or a history of specific heart surgeries, you may not be eligible. If you join, you can expect to undergo the TAVR procedure while researchers observe and record how well the coronary arteries can be accessed afterward. This research could help improve future heart procedures for patients like you.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Patients undergoing elective transfemoral TAVR with the Evolut THV (Medtronic, Minneapolis, MN, USA).
  • 2. Written informed consent to participate in the study.
  • Exclusion Criteria:
  • 1. Hemodynamic or respiratory instability immediately prior to TAVR or during TAVR.
  • 2. Advanced chronic kidney disease, defined as a GFR \<30 ml/min.
  • 3. Valve-in-valve TAVR
  • 4. Prior CABG
  • 5. Aorto-ostial coronary artery disease.
  • 6. Prior PCI of the left main or right coronary ostium

About University Of British Columbia

The University of British Columbia (UBC) is a leading research institution located in Vancouver, Canada, renowned for its commitment to advancing health sciences through innovative research and education. As a prominent clinical trial sponsor, UBC leverages its interdisciplinary expertise and state-of-the-art facilities to conduct rigorous clinical studies aimed at improving patient outcomes across various medical fields. The university fosters collaborations with healthcare professionals, industry partners, and community stakeholders to translate research findings into practical applications, thereby contributing to the global advancement of medicine and public health.

Locations

Vancouver, British Columbia, Canada

Vancouver, British Columbia, Canada

Toronto, Ontario, Canada

Harrisburg, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Janarthanan Sathananthan, MBChB, MPH

Principal Investigator

University of British Columbia

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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