CAN-ACCESS: Coronary Access After Supra-Annular THV Implantation

Sponsor

University of British Columbia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05075590

Collaborator

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

Enrollment

Locations

10.2

Anticipated Duration (Months)

12.5

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Angiography Transcatheter Aortic Valve Replacement	Diagnostic Test: Coronary Angiography	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 27, 2021

Anticipated Primary Completion Date :

Jul 14, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Outcome Measures

Primary Outcome Measures

The ability to selectively engage and obtain diagnostic epicardial coronary angiography images from the right and left coronary ostia [Immediately post-TAVR]
Coronary engagement will be classified as: 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. Successful if selective engagement is achieved with placement of the coronary catheter in the coronary ostia and adequate opacification of the coronary vessels. Unsuccessful if engagement is not possible and there is insufficient opacification of the coronary vessels.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients undergoing elective transfemoral TAVR with the Evolut THV (Medtronic, Minneapolis, MN, USA).
Written informed consent to participate in the study.

Exclusion Criteria:

Hemodynamic or respiratory instability immediately prior to TAVR or during TAVR.
Advanced chronic kidney disease, defined as a GFR <30 ml/min.
Valve-in-valve TAVR
Prior CABG
Aorto-ostial coronary artery disease.
Prior PCI of the left main or right coronary ostium

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UPMC Harrisburg	Harrisburg	Pennsylvania	United States	17101
2	Vancouver General Hospital	Vancouver	British Columbia	Canada	V5Z 1M9
3	St. Paul's Hospital	Vancouver	British Columbia	Canada	V6Z 1Y6
4	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5