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Clinical Trials/NCT06284837
NCT06284837CompletedNot Applicable

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

The Alfred3 sites in 1 country542 target enrollmentStarted: February 2, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
542
Locations
3
Primary Endpoint
All clinically relevant bleeding and all vascular complications

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Radial secondary access

Active Comparator

Intervention: Access site (Other)

Femoral secondary access

Active Comparator

Intervention: Access site (Other)

Outcomes

Primary Outcomes

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

  • Conversion rate to alternative vascular access site(30 days)
  • Tertiary site utilised to treat vascular complication(30 days)
  • Failure to perform angiogram of primary access site at completion of TAVI(1 day)
  • Major adverse cardiovascular events(30 days)
  • All-cause death(30 days)
  • Stroke(30 days)
  • Myocardial infarction(30 days)
  • Length of stay post-procedure(30 days)
  • Overall procedure duration(1 day)
  • Radiation dose(1 day)
  • Myocardial infarction(30 days)
  • Length of stay post-procedure(30 days)
  • Overall procedure duration(1 day)
  • All clinically relevant bleeding (BARC ≥2), overall and by access site(30 days)
  • All vascular complications, overall and by access site(30 days)
  • All-cause death(30 days)
  • Stroke(30 days)
  • Major adverse cardiovascular events(30 days)
  • Radiation dose(1 day)
  • Conversion rate to alternative vascular access site(30 days)
  • Tertiary site utilised to treat vascular complication(30 days)
  • Failure to perform angiogram of primary access site at completion of TAVI(1 day)

Investigators

Sponsor
The Alfred
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jennifer Zhou

Principal Investigator

The Alfred

Study Sites (3)

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