To determine the optimal technique and equipment for selective coronary engagement specifically following Evolut THV implantation using commissural alignment.
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
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
50
Following TAVR, the operators will attempt to selectively engage both the right and left coronary arteries. Catheter choice and engagement technique will be at the discretion of the operator.
UPMC Harrisburg
Harrisburg, Pennsylvania, United States
NOT_YET_RECRUITINGVancouver General Hospital
Vancouver, British Columbia, Canada
RECRUITINGSt. Paul's Hospital
Vancouver, British Columbia, Canada
RECRUITINGThe ability to selectively engage and obtain diagnostic epicardial coronary angiography images from the right and left coronary ostia
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.
Time frame: Immediately post-TAVR
Total fluoroscopic time (mins) from catheter insertion to selective coronary engagement.
Time frame: During TAVR procedure
Total contrast use (ml) from catheter insertion to selective coronary engagement.
Time frame: During TAVR procedure
Type of wire and catheter used for successful right and left coronary engagement
Reporting of the wire and catheter type will be collected
Time frame: During TAVR procedure
Total number and types of wires and catheters used.
Time frame: During TAVR procedure
Description of type of technique utilized to achieve selective coronary engagement.
Report of description will be collected
Time frame: During TAVR procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
NOT_YET_RECRUITING