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

Launched by THE ALFRED · Feb 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the best way to access the blood vessels during a procedure called transcatheter aortic valve implantation (TAVI), which is a treatment for severe aortic stenosis, a heart valve problem. The researchers want to compare two different methods of secondary access: using the radial artery in the wrist or the femoral artery in the groin. Previous studies suggest that using the radial access may lead to fewer complications than the femoral access, but this trial aims to gather more definitive evidence by randomly assigning participants to one of the two methods.

To be eligible for this trial, participants need to be over 18 years old and scheduled for a transfemoral TAVI using a specific type of heart valve. They also need to have suitable blood vessels for both the wrist and groin access. Those who have certain medical conditions, such as being on dialysis or having previously had trouble accessing the radial arteries, would not be eligible. Participants in the trial can expect to receive the TAVI procedure using one of the two access methods and will help contribute to understanding which approach is safer and more effective for patients like them.

Gender

ALL

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