Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation?

NARecruitingINTERVENTIONAL
Enrollment

542

Participants

Timeline

Start Date

December 4, 2023

Primary Completion Date

July 31, 2026

Study Completion Date

August 31, 2026

Conditions
Valve Stenoses, Aortic
Interventions
OTHER

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.

Trial Locations (3)

3004

RECRUITING

Alfred Health, Melbourne

3121

NOT_YET_RECRUITING

Epworth Healthcare, Melbourne

3144

NOT_YET_RECRUITING

Cabrini Health, Melbourne

Sponsors
All Listed Sponsors
collaborator

Epworth Healthcare

OTHER

collaborator

Cabrini Health

OTHER

lead

The Alfred

OTHER