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

Not Applicable

Recruiting

• Conditions: Valve Stenoses, Aortic

• Registration Number: NCT06284837
• Lead Sponsor: The Alfred

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-04
• Study First Submitted: 2023-12-08
• Study First Submitted QC: 2024-02-27
• Study First Posted: 2024-02-29
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-02
• Last Update Posted: 2025-10-07
• Primary Completion: 2026-07
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 542

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
All clinically relevant bleeding and all vascular complications	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 Outcome Measures

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

Trial Locations

Locations (3)

Alfred Health; 🇦🇺 Melbourne, Victoria, Australia

Epworth Healthcare; 🇦🇺 Melbourne, Victoria, Australia

Cabrini Health; 🇦🇺 Melbourne, Victoria, Australia