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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \>18 years

• Undergoing transfemoral TAVI with any commercially available transcatheter heart valve

• Suitable radial and secondary femoral access

Locations
Other Locations
Australia
Alfred Health
RECRUITING
Melbourne
Cabrini Health
NOT_YET_RECRUITING
Melbourne
Epworth Healthcare
NOT_YET_RECRUITING
Melbourne
Contact Information
Primary
Jennifer Zhou, MBBS, BMedSc
je.zhou@alfred.org.au
+61390763263
Time Frame
Start Date: 2023-12-04
Estimated Completion Date: 2026-08
Participants
Target number of participants: 542
Treatments
Active_comparator: Radial secondary access
Active_comparator: Femoral secondary access
Sponsors
Leads: The Alfred
Collaborators: Epworth Healthcare, Cabrini Health

This content was sourced from clinicaltrials.gov

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