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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age \>18 years - Undergoing transfemoral TAVI with any commercially available transcatheter heart valve - Suitable radial and secondary femoral access Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

OTHER

Access site

The SAFER-TAVI trial is randomized study comparing secondary access via a transradial versus transfemoral approach among patients undergoing transfemoral TAVI for aortic valve disease. Secondary access is gained along with primary access at the commencement of the TAVI procedure and is used for aortography before and after valve deployment and for assessment of the primary femoral access site after closure to confirm haemostasis. For patients assigned to radial access, the radial sheath will be removed using a radial band at the end of the procedure. For patients assigned to femoral access, the puncture site will be obtained under ultrasound guidance and fluoroscopic landmark identification. Unless contraindicated, the use of vascular closure devices will be recommended for all femoral cases. The choice of closure device is at the discretion of the operator. Catheters used in the access groups will be 5 or 6 French size at the discretion of the operator.

Locations (3)

Alfred Health
Melbourne, Victoria, Australia
Epworth Healthcare
Melbourne, Victoria, Australia
Cabrini Health
Melbourne, Victoria, Australia