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New heart valve device tested in 200 patients

NCT ID NCT04555967

Disease control Sponsor: Edwards Lifesciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a newer version of a heart valve device, called the SAPIEN 3 Ultra, in 200 people with severe aortic stenosis (a narrowed heart valve). The valve is implanted through a tube in an artery, avoiding open-heart surgery. Researchers are checking how well the valve works and tracking safety issues like stroke or bleeding.

What this could mean

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

Active substance
SAPIEN 3 Ultra heart valve device
What this could lead to
If successful, this could confirm that the SAPIEN 3 Ultra valve is safe and effective for treating severe aortic stenosis without open-heart surgery.
What could go wrong
This is a post-market study, so the device is already approved; risks include stroke, bleeding, or need for a pacemaker. Results may not apply to all patients.

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.

Participants

200 people

The number who actually took part.

Started

Jun 2020

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Subjects with symptomatic, severe, calcific aortic stenosis treated per the indications for use in the Instructions for Use

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.

1. Subject meets the criteria per the Indication and Contraindications according to the current IFUs. * Indication for Use: The Edwards SAPIEN 3 Ultra THV, the Edwards SAPIEN 3 THV, and the associated delivery systems are indicated for use in patients with severe, symptomatic, calcific aortic valve stenosis who are judged by a Heart Team, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 3% at 30 days, based on the STS risk score and other clinical comorbidities unmeasured by the STS risk calculator). * Contraindications: Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis; Inability to tolerate anticoagulation/antiplatelet therapy. 2. Subject has provided written informed consent to comply with all study procedures and follow-up visits

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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

Contacts and locations

Locations

  • Aarhus University Hospital, Skejby

    Aarhus, 8200, Denmark

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117, Germany

  • Deutsches Herzzentrum Berlin

    Berlin, 13353, Germany

  • Helsinki University Hospital

    Helsinki, 00100, Finland

  • King's College Hospital London

    London, SE5 9RS, United Kingdom

  • Medizinische Universitaet Wien

    Vienna, 1090, Austria

  • Ospedale G. Pasquinucci

    Massa, 54100, Italy

  • Royal Victoria Hospital Belfast

    Belfast, BT12 6BA, United Kingdom

  • St. Paul's Hospital Vancouver

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX, Netherlands

  • Universitares Herzzentrum Hamburg

    Hamburg, 20251, Germany

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