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

Valve Stenoses, Aortic Clinical Trial

— SAFER-TAVI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06284837
• Other study ID #: HREC/99382/Alfred-2023
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2023
• Est. completion date: August 2025

Study information

• Verified date: February 2024
• Source: The Alfred
• Contact: Jennifer Zhou, MBBS, BMedSc
• Phone: +61390763263
• Email: je.zhou[@]alfred.org.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: August 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Valve Stenoses, Aortic

Intervention

Other:
• Access site
The SAFER-TAVI trial is randomized study comparing secondary access via a transradial versus transfemoral approach among patients undergoing transfemoral TAVI for aortic valve disease. Secondary access is gained along with primary access at the commencement of the TAVI procedure and is used for aortography before and after valve deployment and for assessment of the primary femoral access site after closure to confirm haemostasis. For patients assigned to radial access, the radial sheath will be removed using a radial band at the end of the procedure. For patients assigned to femoral access, the puncture site will be obtained under ultrasound guidance and fluoroscopic landmark identification. Unless contraindicated, the use of vascular closure devices will be recommended for all femoral cases. The choice of closure device is at the discretion of the operator. Catheters used in the access groups will be 5 or 6 French size at the discretion of the operator.

Locations

Country	Name	City	State
Australia	Alfred Health	Melbourne	Victoria
Australia	Cabrini Health	Melbourne	Victoria
Australia	Epworth Healthcare	Melbourne	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
The Alfred	Cabrini Health, Epworth Healthcare

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All bleeding and vascular complications	The composite of all bleeding (according to BARC criteria) and vascular complications (according to VARC-3 criteria)	30 days
Secondary	All bleeding	According to BARC criteria	30 days
Secondary	All vascular complications	According to VARC-3 criteria	30 days
Secondary	All-cause death	According to VARC-3 criteria	30 days
Secondary	Stroke	According to VARC-3 criteria	30 days
Secondary	Myocardial infarction	According to VARC-3 criteria	30 days
Secondary	Major adverse cardiovascular events	The composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke	30 days
Secondary	Length of stay post-procedure	Length of stay post-procedure measured in time (days) from procedure to discharge	30 days
Secondary	Overall procedure duration	TAVI procedure duration measured in time (minutes)	1 day
Secondary	Radiation dose	Radiation dose measured as air kerma in milligrays	1 day
Secondary	Conversion rate to alternative vascular access site	Conversion rate to alternative vascular access site	30 days
Secondary	Tertiary site utilised to treat vascular complication	Tertiary site utilised to treat vascular complication	30 days
Secondary	Failure to perform angiogram of primary access site at completion of TAVI	Failure to perform angiogram of primary access site at completion of TAVI	1 day