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Study identifier: NCT06284837 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Valve Stenoses, Aortic  ·  Sponsor: The Alfred

PhaseNA
Planned participants542
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 tr…

This description comes directly from the study's public registry record.

Talk to the study team

Jennifer Zhou, MBBS, BMedSc  ·  +61390763263  ·  je.zhou@alfred.org.au

Always discuss trial participation with your own doctor first.

Locations (3)

Alfred HealthMelbourne, Victoria, AustraliaRecruiting
Epworth HealthcareMelbourne, Victoria, AustraliaRecruiting
Cabrini HealthMelbourne, Victoria, AustraliaRecruiting

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Source record: clinicaltrials.gov/study/NCT06284837