Coronary Access After Supra-Annular THV Implantation

Not Applicable

Recruiting

• Conditions: Transcatheter Aortic Valve Replacement; Coronary Angiography

• Registration Number: NCT05075590
• Lead Sponsor: University of British Columbia

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-10-07
• Study First Posted: 2021-10-13
• Study Start: 2021-10-27
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-20
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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: 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.

Secondary Outcome Measures

Name	Time	Method
Total contrast use (ml) from catheter insertion to selective coronary engagement.	During TAVR procedure
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
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 fluoroscopic time (mins) from catheter insertion to selective coronary engagement.	During TAVR procedure

Trial Locations

Locations (4)

UPMC Harrisburg; 🇺🇸 Harrisburg, Pennsylvania, United States

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada