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

NCT06284837 | Recruiting DMC

• 1 other identifier: HREC/99382/Alfred-2023
• Study Type: interventional
• Target: 542
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Valve Stenoses, Aortic

Keywords

TAVI; TAVR; transcatheter aortic valve replacement; transcatheter aortic valve implantation; aortic stenosis; vascular access; primary access; secondary access

Outcome Measures

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.

  30 days

Secondary Outcomes (12)

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

  30 days

• All vascular complications, overall and by access site

  30 days

• All-cause death

  30 days

• Stroke

  30 days

• Myocardial infarction

  30 days

Study Arms (2)

Radial secondary access

ACTIVE COMPARATOR

Other: Access site

Femoral secondary access

ACTIVE COMPARATOR

Other: Access site

Interventions

Access site OTHER

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.

Femoral secondary access; Radial secondary access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Undergoing transfemoral TAVI with any commercially available transcatheter heart valve
• Suitable radial and secondary femoral access

You may not qualify if:

• 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

Sponsors & Collaborators

• The Alfred: lead
• Epworth Healthcare: collaborator
• Cabrini Health: collaborator

Study Sites (3)

Alfred Health

Melbourne, Victoria, 3004, Australia

RECRUITING

Epworth Healthcare

Melbourne, Victoria, 3121, Australia

RECRUITING

Cabrini Health

Melbourne, Victoria, 3144, Australia

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Antony Walton, MBBS

  The Alfred and Epworth Healthcare

  PRINCIPAL INVESTIGATOR

• Dion Stub, MBBS, PhD

  The Alfred and Cabrini Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Zhou, MBBS, BMedSc

CONTACT

+61390763263; je.zhou@alfred.org.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: SAFER-TAVI trial is a multicentre registry-nested, randomised controlled trial comparing transradial versus transfemoral secondary access in patients undergoing transfemoral TAVI for aortic valve disease.

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: February 29, 2024
• Study Start: December 4, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2025-10

Locations

AU (3)