Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation? (SAFER-TAVI)

The Alfred

Status

Enrolling

Conditions

Valve Stenoses, Aortic

Treatments

Other: Access site

Study type

Interventional

Funder types

Other

Identifiers

NCT06284837

HREC/99382/Alfred-2023

Details and patient eligibility

About

Transcatheter aortic valve implantation (TAVI) is a well-known safe and effective treatment for anatomically suitable patients with severe aortic stenosis (AS). Despite rapid improvements in TAVI technique and technology, vascular and bleeding complications from both primary and secondary access sites remain significant, with approximately 25% of access related complications thought to be related to secondary access. The transfemoral route remains the most common approach for primary access during TAVI due to proven safety and efficacy. Secondary access during TAVI, which is needed for angiographic guidance, has drawn little attention in randomised trials of TAVI. In coronary intervention, the radial approach is now preferred due to high quality evidence suggesting lower bleeding and vascular complications compared to the femoral approach. Whilst randomised control trials comparing radial vs femoral as secondary access are lacking in the TAVI setting, observational studies comparing the two secondary access routes have shown a lower risk of bleeding and vascular complications with radial compared to femoral access. A systematic review of all the major observational trials also suggests that radial access might reduce risk of bleeding, vascular complications, and even 30-day mortality, but these data are limited to observational trials and there are no randomised controlled data to confirm these findings. Accordingly, we aim to undertake a multicentre, randomised controlled trial among patients undergoing transfemoral TAVI to assess if radial secondary access is superior to femoral secondary access.

Enrollment

542 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age >18 years
Undergoing transfemoral TAVI with any commercially available transcatheter heart valve
Suitable radial and secondary femoral access

Exclusion criteria

Primary arterial access via surgical cut-down
Inadequate contralateral femoral artery access and/or bilateral radial artery access as determined by the interventional cardiologist
Previously failed attempt to access bilateral radial arteries.
Patient on hemodialysis