Coronary Access After Supra-Annular THV Implantation (CAN-ACCESS)

December 13, 2023 updated by: David Wood, University of British Columbia

Coronary ANgiography and ACCESS Following Implantation of a Supra-Annular Transcatheter Heart Valve With Commissural Alignment: The CAN-ACCESS Pilot Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Recruiting
        • St. Paul's Hospital
        • Principal Investigator:
          • Janarthanan Sathananthan, MBChB, MPH
        • Contact:
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • Vancouver General Hospital
        • Contact:
        • Principal Investigator:
          • Janarthanan Sathananthan, MBChB, MPH
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Not yet recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Sam Radhakrishnan, MD
  • United States
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17101
        • Not yet recruiting
        • UPMC Harrisburg
        • Contact:
          • Anita Todd, RN, CCRC, ACRP-MDP
          • Phone Number: 3002 717.731.0101
          • Email: toddag@upmc.edu
        • Principal Investigator:
          • Hemal Gada, MD

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The ability to selectively engage and obtain diagnostic epicardial coronary angiography images from the right and left coronary ostia
Time Frame: Immediately post-TAVR

Coronary engagement will be classified as:

  1. Partially successful if non-selective engagement is achieved (catheter is unable to be placed in the coronary ostia) and there is adequate opacification of the coronary vessels.
  2. Successful if selective engagement is achieved with placement of the coronary catheter in the coronary ostia and adequate opacification of the coronary vessels.
  3. Unsuccessful if engagement is not possible and there is insufficient opacification of the coronary vessels.
Immediately post-TAVR

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total fluoroscopic time (mins) from catheter insertion to selective coronary engagement.
Time Frame: During TAVR procedure
During TAVR procedure
Total contrast use (ml) from catheter insertion to selective coronary engagement.
Time Frame: During TAVR procedure
During TAVR procedure
Type of wire and catheter used for successful right and left coronary engagement
Time Frame: During TAVR procedure
Reporting of the wire and catheter type will be collected
During TAVR procedure
Total number and types of wires and catheters used.
Time Frame: During TAVR procedure
During TAVR procedure
Description of type of technique utilized to achieve selective coronary engagement.
Time Frame: During TAVR procedure
Report of description will be collected
During TAVR procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Medtronic
The Centre for Cardiovascular Innovation - Centre d'Innovation Cardiovasculaire (CCI-CIC)

Investigators

  • Principal Investigator: Janarthanan Sathananthan, MBChB, MPH, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

October 27, 2021

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

September 14, 2021

First Submitted That Met QC Criteria

October 7, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H21-01704

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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