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

University of British Columbia

Status: Enrolling

Conditions: Coronary Angiography; Transcatheter Aortic Valve Replacement

Treatments: Diagnostic Test: Coronary Angiography

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05075590

H21-01704

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)