Coronary Access After Supra-Annular THV Implantation

Last updated: December 13, 2023
Sponsor: University of British Columbia
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Coronary Angiography

Clinical Study ID

NCT05075590
H21-01704
  • Ages > 18
  • All Genders

Study Summary

To determine the optimal technique and equipment for selective coronary engagement specifically following Evolut THV implantation using commissural alignment.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Coronary Angiography
Phase:
Study Start date:
October 27, 2021
Estimated Completion Date:
July 31, 2024

Study Description

Patients will undergo elective transfemoral TAVR with the Evolut THV. The operators will attempt to selectively engage both the right and left coronary arteries through standardized angiographic views. The CCI-CIC CoreLabs will adjudicate angiographic views, post-TAVR CT scan, and determine if the coronaries were selectively engaged. Catheter choice, adjunctive tools if needed (e.g guide extension, wires etc) and engagement technique will be at the discretion of the operator. All images and fluoroscopic views will be anonymized, saved and imported to the CCI-CIC Angiographic and CT CoreLabs.

Statistical analysis:

Patient baseline and outcome data will be presented as mean and standard deviation (SD) for normally distributed variables, median and interquartile range (IQR) for non-normally distributed variables, and frequency and proportion for categorical variables.

Connect with a study center

  • St. Paul's Hospital

    Vancouver, British Columbia V6Z 1Y6
    Canada

    Active - Recruiting

  • Vancouver General Hospital

    Vancouver, British Columbia V5Z 1M9
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • UPMC Harrisburg

    Harrisburg, Pennsylvania 17101
    United States

    Site Not Available

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