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

August 10, 2026 updated by: Jennifer Zhou, The Alfred
Transcatheter aortic valve implantation (TAVI) is a well-known safe and effective treatment for anatomically suitable patients with severe aortic stenosis (AS). Despite rapid improvements in TAVI technique and technology, vascular and bleeding complications from both primary and secondary access sites remain significant, with approximately 25% of access related complications thought to be related to secondary access. The transfemoral route remains the most common approach for primary access during TAVI due to proven safety and efficacy. Secondary access during TAVI, which is needed for angiographic guidance, has drawn little attention in randomised trials of TAVI. In coronary intervention, the radial approach is now preferred due to high quality evidence suggesting lower bleeding and vascular complications compared to the femoral approach. Whilst randomised control trials comparing radial vs femoral as secondary access are lacking in the TAVI setting, observational studies comparing the two secondary access routes have shown a lower risk of bleeding and vascular complications with radial compared to femoral access. A systematic review of all the major observational trials also suggests that radial access might reduce risk of bleeding, vascular complications, and even 30-day mortality, but these data are limited to observational trials and there are no randomised controlled data to confirm these findings. Accordingly, we aim to undertake a multicentre, randomised controlled trial among patients undergoing transfemoral TAVI to assess if radial secondary access is superior to femoral secondary access.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
542

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Alfred Health
      • Melbourne, Victoria, Australia, 3144
        • Cabrini Health
      • Melbourne, Victoria, Australia, 3121
        • Epworth HealthCare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All clinically relevant bleeding and all vascular complications
Time Frame: 30 days
The composite of all clinically relevant bleeding (defined as Bleeding Academic Research Consortium [BARC] type ≥2) and vascular complications (Valve Academic Research Consortium [VARC3] criteria) at 30 days.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events
Time Frame: 30 days
The composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke
30 days
Length of stay post-procedure
Time Frame: 30 days
Length of stay post-procedure measured in time (days) from procedure to discharge
30 days
Overall procedure duration
Time Frame: 1 day
TAVI procedure duration measured in time (minutes)
1 day
Radiation dose
Time Frame: 1 day
Radiation dose measured as air kerma in milligrays
1 day
Conversion rate to alternative vascular access site
Time Frame: 30 days
Conversion rate to alternative vascular access site
30 days
Tertiary site utilised to treat vascular complication
Time Frame: 30 days
Tertiary site utilised to treat vascular complication
30 days
Failure to perform angiogram of primary access site at completion of TAVI
Time Frame: 1 day
Failure to perform angiogram of primary access site at completion of TAVI
1 day
All clinically relevant bleeding (BARC ≥2), overall and by access site
Time Frame: 30 days
Using BARC criteria
30 days
All vascular complications, overall and by access site
Time Frame: 30 days
Using VARC-3 criteria
30 days
All-cause death
Time Frame: 30 days
Using VARC-3 criteria
30 days
Stroke
Time Frame: 30 days
Using VARC-3 criteria
30 days
Myocardial infarction
Time Frame: 30 days
Using VARC-3 criteria
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Alfred

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Epworth Healthcare
Cabrini Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Antony Walton, MBBS, The Alfred and Epworth Healthcare
  • Principal Investigator: Dion Stub, MBBS, PhD, The Alfred and Cabrini Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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