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NCT Number: NCT06284837

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alfred Health, Melbourne, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. All clinically relevant bleeding and all vascular complications

    Time frame: 30 days

    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.

Secondary outcomes

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

    Time frame: 30 days

    Using BARC criteria

  2. All vascular complications, overall and by access site

    Time frame: 30 days

    Using VARC-3 criteria

  3. All-cause death

    Time frame: 30 days

    Using VARC-3 criteria

  4. Stroke

    Time frame: 30 days

    Using VARC-3 criteria

  5. Myocardial infarction

    Time frame: 30 days

    Using VARC-3 criteria

  6. Major adverse cardiovascular events

    Time frame: 30 days

    The composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke

  7. Length of stay post-procedure

    Time frame: 30 days

    Length of stay post-procedure measured in time (days) from procedure to discharge

  8. Overall procedure duration

    Time frame: 1 day

    TAVI procedure duration measured in time (minutes)

  9. Radiation dose

    Time frame: 1 day

    Radiation dose measured as air kerma in milligrays

  10. Conversion rate to alternative vascular access site

    Time frame: 30 days

    Conversion rate to alternative vascular access site

  11. Tertiary site utilised to treat vascular complication

    Time frame: 30 days

    Tertiary site utilised to treat vascular complication

  12. Failure to perform angiogram of primary access site at completion of TAVI

    Time frame: 1 day

    Failure to perform angiogram of primary access site at completion of TAVI

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Zhou, MBBS, BMedSc

CONTACT

[email protected]

+61390763263

Sponsors and collaborators

Lead sponsor

The Alfred

Other

Collaborators

  • Cabrini Health
  • Epworth Healthcare

Registry information

Acronym: SAFER-TAVI

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 29, 2024
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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