542
Participants
Start Date
December 4, 2023
Primary Completion Date
July 31, 2026
Study Completion Date
August 31, 2026
Access site
The SAFER-TAVI trial is randomized study comparing secondary access via a transradial versus transfemoral approach among patients undergoing transfemoral TAVI for aortic valve disease. Secondary access is gained along with primary access at the commencement of the TAVI procedure and is used for aortography before and after valve deployment and for assessment of the primary femoral access site after closure to confirm haemostasis. For patients assigned to radial access, the radial sheath will be removed using a radial band at the end of the procedure. For patients assigned to femoral access, the puncture site will be obtained under ultrasound guidance and fluoroscopic landmark identification. Unless contraindicated, the use of vascular closure devices will be recommended for all femoral cases. The choice of closure device is at the discretion of the operator. Catheters used in the access groups will be 5 or 6 French size at the discretion of the operator.
RECRUITING
Alfred Health, Melbourne
NOT_YET_RECRUITING
Epworth Healthcare, Melbourne
NOT_YET_RECRUITING
Cabrini Health, Melbourne
Collaborators (2)
Epworth Healthcare
OTHER
Cabrini Health
OTHER
The Alfred
OTHER