Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation? (SAFER-TAVI)

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.

Study Overview

• Status: Recruiting
• Conditions: Valve Stenoses, Aortic
• Intervention / Treatment: Other: Access site

• Study Type: Interventional
• Enrollment (Estimated): 560
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Zhou, MBBS, BMedSc; Phone Number: +61390763263; Email: je.zhou@alfred.org.au

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • Alfred Health
      • Contact: Jennifer Zhou, MBBS, BMedSc; Email: je.zhou@alfred.org.au
      • Principal Investigator: Antony Walton, MBBS
      • Principal Investigator: Dion Stub, MBBS, PhD
    • Melbourne, Victoria, Australia, 3121
      • Not yet recruiting
      • Epworth Healthcare
      • Contact: Jennifer Zhou, MBBS, BMedSc; Email: je.zhou@alfred.org.au
      • Principal Investigator: Antony Walton, MBBS
    • Melbourne, Victoria, Australia, 3144
      • Not yet recruiting
      • Cabrini Health
      • Contact: Jennifer Zhou, MBBS, BMedSc; Email: je.zhou@alfred.org.au
      • Principal Investigator: Dion Stub, MBBS, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Radial secondary access	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.
Active Comparator: Femoral secondary access	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Alfred
• Collaborators: Epworth Healthcare; Cabrini Health
• Investigators: Principal Investigator: Antony Walton, MBBS, The Alfred and Epworth Healthcare; Principal Investigator: Dion Stub, MBBS, PhD, The Alfred and Cabrini Health

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: TAVI; Primary access; Secondary access
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: HREC/99382/Alfred-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Yes if ethics is approved

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No