Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Access site.
- Who it may be relevant to
- Registry conditions: Valve Stenoses, Aortic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- All clinically relevant bleeding and all vascular complications [Time frame: 30 days]
Secondary outcome measures (12)
- All clinically relevant bleeding (BARC ≥2), overall and by access site [Time frame: 30 days]
- All vascular complications, overall and by access site [Time frame: 30 days]
- All-cause death [Time frame: 30 days]
- Stroke [Time frame: 30 days]
- Myocardial infarction [Time frame: 30 days]
- Major adverse cardiovascular events [Time frame: 30 days]
- Length of stay post-procedure [Time frame: 30 days]
- Overall procedure duration [Time frame: 1 day]
- Radiation dose [Time frame: 1 day]
- Conversion rate to alternative vascular access site [Time frame: 30 days]
- Tertiary site utilised to treat vascular complication [Time frame: 30 days]
- Failure to perform angiogram of primary access site at completion of TAVI [Time frame: 1 day]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Australia · 3 centers
- Alfred Health — Melbourne
- Epworth Healthcare — Melbourne
- Cabrini Health — Melbourne
Identifiers
NCT: NCT06284837 · HREC/99382/Alfred-2023