Clinical trial NCT06284837: Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation?
Official title: Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Valve Stenoses, Aortic
Keywords: TAVI
Primary access
Secondary access
Lead sponsor: The Alfred
Sponsor class: OTHER
Collaborators: name: Epworth Healthcare
name: Cabrini Health
First posted: 2024-02-29
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Transcatheter aortic valve implantation (TAVI) is a well known safe treatment for severe aortic stenosis. To perform TAVI safely, there is a need for two vascular entry (access) sites: the primary and secondary access sites. While the femoral approach remains the most common site for primary access, secondary access (which is needed for guidance during the procedure) has drawn little attention in trials of TAVI. The two secondary access sites most commonly used are the radial (through an artery in the wrist) and femoral (through an artery in the groin) access sites. Observational studies comparing the two have shown a lower risk of complications with radial access compared to femoral access, but there are no randomized controlled data to confirm these findings. Accordingly, investigators aim to undertake a multicenter, randomized controlled trial among patients who are undergoing transfemoral TAVI, to assess if radial access is superior to femoral access as a secondary access site.


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

Primary outcomes:
measure: All bleeding and vascular complications
timeFrame: 30 days
Secondary outcomes:
measure: All bleeding
timeFrame: 30 days
measure: All vascular complications
timeFrame: 30 days
measure: All-cause death
timeFrame: 30 days
measure: Stroke
timeFrame: 30 days
measure: Myocardial infarction
timeFrame: 30 days
measure: Major adverse cardiovascular events
timeFrame: 30 days
measure: Length of stay post-procedure
timeFrame: 30 days
measure: Overall procedure duration
timeFrame: 1 day
measure: Radiation dose
timeFrame: 1 day
measure: Conversion rate to alternative vascular access site
timeFrame: 30 days
measure: Tertiary site utilised to treat vascular complication
timeFrame: 30 days
measure: Failure to perform angiogram of primary access site at completion of TAVI
timeFrame: 1 day
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Health
state: Victoria
city: Melbourne
country: Australia
facility: Epworth Healthcare
state: Victoria
city: Melbourne
country: Australia
facility: Cabrini Health
state: Victoria
Study officials:
affiliation: The Alfred and Epworth Healthcare
name: Antony Walton, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: The Alfred and Cabrini Health
name: Dion Stub, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: