Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation?
Key facts
- Who runs it
- The Alfred
- Where
- Australia3 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 542 people enrolled
- Started
- 2 Feb 2024
- Ended
- 10 Jun 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Access site
- Record updated
- 12 August 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- Age >18 years
- Undergoing transfemoral TAVI with any commercially available transcatheter heart valve
- Suitable radial and secondary femoral access
Who cannot take part
- Primary arterial access via surgical cut-down
- Previously failed attempt to access bilateral radial arteries
- Inadequate contralateral femoral artery access and/or bilateral radial artery access as determined by the interventional cardiologist
- Patient on hemodialysis
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Radial secondary accessExisting treatment, for comparison
Treatment: Access site
- Femoral secondary accessExisting treatment, for comparison
Treatment: Access site
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 12 August 2026