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

Recruiting now · Not applicable

Conditions studied: Valve Stenoses, Aortic

In brief

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.

Key facts

Study ID

NCT06284837

Run by

The Alfred

People needed

542

Starts

2023-12-04

Expected to finish

2026-08-01

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Alfred Health — Melbourne, Victoria, Australia (enrolling)
• Epworth Healthcare — Melbourne, Victoria, Australia (enrolling)
• Cabrini Health — Melbourne, Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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