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

Not Applicable

Recruiting

• Conditions: Valve Stenoses, Aortic
• Interventions: Other: Access site

• Registration Number: NCT06284837
• Lead Sponsor: The Alfred

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-04
• Study First Submitted: 2023-12-08
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-27
• Study First Posted: 2024-02-29
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-04
• Primary Completion: 2025-07
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 560

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

Arm && Interventions

Group	Intervention	Description
Radial secondary access	Access site	-
Femoral secondary access	Access site	-

Primary Outcome Measures

Name	Time	Method
All bleeding and vascular complications	30 days	The composite of all bleeding (according to BARC criteria) and vascular complications (according to VARC-3 criteria)

Secondary Outcome Measures

Name	Time	Method
All bleeding	30 days	According to BARC criteria
All-cause death	30 days	According to VARC-3 criteria
All vascular complications	30 days	According to VARC-3 criteria
Stroke	30 days	According to VARC-3 criteria
Myocardial infarction	30 days	According to 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
Tertiary site utilised to treat vascular complication	30 days	Tertiary site utilised to treat vascular complication
Conversion rate to alternative vascular access site	30 days	Conversion rate to alternative vascular access site
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)

Epworth Healthcare; 🇦🇺 Melbourne, Victoria, Australia

Alfred Health; 🇦🇺 Melbourne, Victoria, Australia

Cabrini Health; 🇦🇺 Melbourne, Victoria, Australia