Valve Stenoses, AorticSAFER-TAVINCT06284837

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

A study testing Access site in people with Valve Stenoses, Aortic, run by The Alfred at 3 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Valve Stenoses, Aortic
What is being tested?: Access site
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 542 participants
Where: 3 sitesAustralia
Study dates: 2 Feb 2024to 10 Jun 2026
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

3 sites in 1 country.

Australia3 sites

Alfred Health
Melbourne, Victoria, 3004
Epworth Healthcare
Melbourne, Victoria, 3121
Cabrini Health
Melbourne, Victoria, 3144

Other trials in Australia

About this study

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
Being tested: Access site
Keywords: TAVI, TAVR, transcatheter aortic valve replacement, transcatheter aortic valve implantation, aortic stenosis, vascular access, primary access, secondary access
Medical subject headings: Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Access siteOther
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.

Study groups in NCT06284837
Study group	Role	What they receive
Radial secondary access	Active comparator	Not described Receives: Other: Access site
Femoral secondary access	Active comparator	Not described Receives: Other: Access site

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 30 days

Secondary outcomes (12)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Feb 202410 Jun 2026

First posted29 Feb 2024
Study start2 Feb 2024
Primary completion10 Jun 2026
Study completion10 Jun 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Valve Stenoses, AorticStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: None (open label)
Enrolment: 542 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06284837
Sponsor's protocol ID: HREC/99382/Alfred-2023
Acronym: SAFER-TAVI
Status last verified: Aug 2026
First submitted: 8 Dec 2023
Last updated: 12 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Yes if ethics is approved

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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