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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Alfred

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 years

Undergoing transfemoral TAVI with any commercially available transcatheter heart valve

Suitable radial and secondary femoral access

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Access site

    Other intervention

    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.

Treatment groups

542 Participants
are divided into 2 treatment groups
Group A: Radial secondary accessActive comparator 1 intervention
Group B: Femoral secondary accessActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

All clinically relevant bleeding and all vascular complications

The composite of all clinically relevant bleeding (defined as Bleeding Academic Research Consortium \[BARC\] type ≥2) and vascular complications (Valve Academic Research Consortium \[VARC3\] criteria) at 30 days.

Time frame
30 days

Secondary outcomes

1

All clinically relevant bleeding (BARC ≥2), overall and by access site

Using BARC criteria

Time frame
30 days
2

All vascular complications, overall and by access site

Using VARC-3 criteria

Time frame
30 days
3

All-cause death

Using VARC-3 criteria

Time frame
30 days
4

Stroke

Using VARC-3 criteria

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Alfred

Lead sponsor

Epworth Healthcare

Collaborator

Cabrini Health

Collaborator