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Heart valve showdown: which TAVI device is better?

NCT ID NCT06470022

Disease control Sponsor: Christian Juhl Terkelsen 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 26, 2026 · Updated 3 times

Summary

This trial compares two different TAVI devices (Evolut FX and Sapien 3 Ultra Resilia) used to replace a narrowed heart valve in people with aortic stenosis. About 1,346 patients will be randomly assigned to get one device or the other. Researchers will track deaths, strokes, valve leaks, and device wear over one year, with follow-up up to 10 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TAVI devices (Medtronic Evolut FX and Edwards Sapien 3 Ultra Resilia)
What this could lead to
If one device proves superior, it could become the preferred option for treating aortic stenosis, potentially reducing complications and improving outcomes.
What could go wrong
This is a head-to-head device comparison, not a new treatment. Both devices are already approved, so the trial may only show small differences. Results are preliminary until long-term follow-up is complete.

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

1,370 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Nov 2036

An estimate. End dates often move.

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

Accepted

You do not need to have the condition being studied to take part.

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: 1. Patient more than 18 years of age. 2. Patient eligible for both Evolut FX and Edwards Sapien 3 Ultra Resilia according to a TAVI heart team conference. 3. The center experience for each of the valves considered should be more than 15 cases a year, and the treating physician should have implanted at least 15 of each valve used in the trial. 4. The center volume should be more than 75 cases a year. 5. The patient has given signed informed consent. 6. TAVI performed via the femoral artery. Exclusion Criteria: None

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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.

Aortic stenosis

Contacts and locations

Locations

  • Department of cardiology, Aarhus University Hospital

    Aarhus, 8200, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.