Coronary Angiography, Transcatheter Aortic Valve Replacement
Conditions
Keywords
elective transfemoral TAVR, Evolut valve, Supra-Annular Transcatheter Heart Valve, Commissural Alignment, Coronary Angiography, Transcatheter Aortic Valve Replacement, Coronary Access
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.
Interventions
DIAGNOSTIC_TESTCoronary Angiography
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.
Sponsors
Medtronic
The Centre for Cardiovascular Innovation - Centre d'Innovation Cardiovasculaire (CCI-CIC)
University of British Columbia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada, United States
Contacts
Primary ContactPavneet Grewal
Outcome results
None listed