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Arm access may be safer for heart valve patients, major trial launches

NCT ID NCT06284837

Knowledge-focused Sponsor: The Alfred Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This study tests whether using the wrist (radial artery) instead of the groin (femoral artery) as a second access point during a minimally invasive heart valve replacement (TAVI) reduces bleeding and other complications. About 542 patients will be randomly assigned to one of the two approaches. The goal is to find the safest way to perform this common heart procedure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

542 people

The number who actually took part.

Started

Feb 2024

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Valve stenoses, aortic

Contacts and locations

Locations

  • Alfred Health

    Melbourne, Victoria, 3004, Australia

  • Cabrini Health

    Melbourne, Victoria, 3144, Australia

  • Epworth Healthcare

    Melbourne, Victoria, 3121, Australia