Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation? (SAFER-TAVI)

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.

Study Overview

• Status: Recruiting
• Conditions: Valve Stenoses, Aortic
• Intervention / Treatment: Other: Access site

• Study Type: Interventional
• Enrollment (Estimated): 542
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Zhou, MBBS, BMedSc; Phone Number: +61390763263; Email: je.zhou@alfred.org.au

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • Alfred Health
      • Contact: Jennifer Zhou, MBBS, BMedSc; Email: je.zhou@alfred.org.au
      • Principal Investigator: Antony Walton, MBBS
      • Principal Investigator: Dion Stub, MBBS, PhD
    • Melbourne, Victoria, Australia, 3144
      • Recruiting
      • Cabrini Health
      • Principal Investigator: Dion Stub, MBBS, PhD
      • Contact: Jennifer Zhou, MBBS, BMedSc; Phone Number: 61390762000; Email: je.zhou@alfred.org.au
    • Melbourne, Victoria, Australia, 3121
      • Recruiting
      • Epworth Healthcare
      • Contact: Jennifer Zhou, MBBS, BMedSc; Email: je.zhou@alfred.org.au
      • Principal Investigator: Antony Walton, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Radial secondary access	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.
Active Comparator: Femoral secondary access	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiovascular events	The composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke	30 days
Length of stay post-procedure	Length of stay post-procedure measured in time (days) from procedure to discharge	30 days
Overall procedure duration	TAVI procedure duration measured in time (minutes)	1 day
Radiation dose	Radiation dose measured as air kerma in milligrays	1 day
Conversion rate to alternative vascular access site	Conversion rate to alternative vascular access site	30 days
Tertiary site utilised to treat vascular complication	Tertiary site utilised to treat vascular complication	30 days
Failure to perform angiogram of primary access site at completion of TAVI	Failure to perform angiogram of primary access site at completion of TAVI	1 day
All clinically relevant bleeding (BARC ≥2), overall and by access site	Using BARC criteria	30 days
All vascular complications, overall and by access site	Using VARC-3 criteria	30 days
All-cause death	Using VARC-3 criteria	30 days
Stroke	Using VARC-3 criteria	30 days
Myocardial infarction	Using VARC-3 criteria	30 days

Collaborators and Investigators

• Sponsor: The Alfred
• Collaborators: Epworth Healthcare; Cabrini Health
• Investigators: Principal Investigator: Antony Walton, MBBS, The Alfred and Epworth Healthcare; Principal Investigator: Dion Stub, MBBS, PhD, The Alfred and Cabrini Health

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: aortic stenosis; transcatheter aortic valve implantation; TAVI; TAVR; vascular access; transcatheter aortic valve replacement; primary access; secondary access
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: HREC/99382/Alfred-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Yes if ethics is approved

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No