Comparing radial and femoral access for heart valve implantation
Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation?
This study tests whether using the wrist instead of the groin for heart valve implantation can help people with severe aortic stenosis have fewer complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 542 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Alfred Academic / other |
| Locations | 3 sites (Melbourne, Victoria and 2 other locations) |
| Trial ID | NCT06284837 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and effectiveness of using radial access compared to femoral access as a secondary entry site during transcatheter aortic valve implantation (TAVI) for patients with severe aortic stenosis. The study aims to provide randomized controlled data to confirm previous observational findings that suggest radial access may reduce complications. Participants will be recruited from multiple centers and will undergo TAVI using commercially available heart valves. The trial will focus on patients who are suitable for both access methods.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are undergoing transfemoral TAVI and have suitable access for both radial and femoral approaches.
Not a fit: Patients who have primary arterial access via surgical cut-down or those on hemodialysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and reduced complications for patients undergoing TAVI.
How similar studies have performed: Previous observational studies have indicated a lower risk of complications with radial access, but this is the first randomized controlled trial to confirm these findings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Melbourne, Victoria and 2 other locations
- Alfred Health — Melbourne, Victoria, Australia (Recruiting)
- Epworth Healthcare — Melbourne, Victoria, Australia (Recruiting)
- Cabrini Health — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Antony Walton, MBBS — The Alfred and Epworth Healthcare
- Study coordinator: Jennifer Zhou, MBBS, BMedSc
- Email: je.zhou@alfred.org.au
- Phone: +61390763263
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.