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Which heart valve works best for small aortic openings? a Head-to-Head trial

NCT ID NCT04372381

Disease control Sponsor: University of Arizona 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This trial compares two types of transcatheter heart valves—one designed to sit above the natural valve opening (supra-annular) and one that sits within it (annular)—in people with severe aortic stenosis and a small aortic annulus (≤23 mm). The goal is to see which valve leads to fewer complications like mismatch or leakage. Participants are randomly assigned to receive either the Medtronic Evolut Pro or the Edwards Sapien Ultra valve.

What this could mean

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

Active substance
transcatheter aortic valve replacement using either a supra-annular valve (Medtronic Evolut Pro) or an annular valve (Edwards Sapien Ultra)
What this could lead to
If one valve type proves superior, it could guide surgeons toward better outcomes for patients with small aortic annuli.
What could go wrong
This is a relatively small, early-stage comparison; results may not apply to all patients, and both valves carry risks like leakage or mismatch.

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.

Started

May 2020

Finished

Apr 2025

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Symptomatic subjects with severe native aortic valve stenosis * aortic valve annulus mean diameter ≤23 mm * Patient meet commercial indication for transcatheter aortic valve replacement (TAVR) * Institutional heart team determines that TAVR is appropriate * Patient's anatomy is appropriate for either Medtronic Evolute or Edwards Sapien 3 Ultra Exclusion Criteria: * Subject unable or unwilling to provide informed consent * Intended concurrent structural heart procedure (e.g. transcatheter mitral valve repair or replacement, left atrial appendage closure) * Renal function precluding the administration of iodinated contrast (eGFR \< 30ml/min/1.73m2). An exception to this exclusion criterion is made if the subject is established on renal replacement therapy and is therefore able to receive intravenous iodinated contrast media * Pregnancy or intent on becoming pregnant prior to completion of all proctocol follow-up procedures * Patients at high risk for coronary obstruction * Patients with low-flow low gradient aortic valve stenosis * patients at high risk for annular rupture with implantation of a balloon expandable valve

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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 valve stenosis Implantation, heart valve prosthesis

Contacts and locations

Locations

  • Banner - University Medical Center, Phoenix campus

    Phoenix, Arizona, 85006, United States

  • Delray Medical Center

    Delray Beach, Florida, 33484, United States

  • Tucson Medical Center

    Tucson, Arizona, 85712, United States

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