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New heart valve aims to improve tricuspid replacement outcomes

NCT ID NCT07684313

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study is testing a new artificial heart valve, called the TRIFORMIS RESILIA, for people who need their tricuspid valve replaced. The tricuspid valve controls blood flow between two right heart chambers. Researchers will follow 75 adults who receive this valve during surgery to see how well it works and how safe it is in real-world use. The study measures blood flow through the valve, heart function, and quality of life over time.

What this could mean

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

Active substance
Edwards TRIFORMIS RESILIA heart valve
What this could lead to
If successful, this study could confirm that the TRIFORMIS RESILIA valve works well and is safe for people needing tricuspid valve replacement, potentially improving heart function and quality of life.
What could go wrong
This is an observational study with no comparison group, so results may not prove the valve is better than other options. Risks include valve leakage, blood flow issues, or need for additional procedures.

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

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2034

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

The target population includes adult candidates who require replacement of their native or prosthetic tricuspid valve.

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: * 18 years or older * Indication for TRIFORMIS valve implant for native or prosthetic valve dysfunction * Provide written informed consent prior to the 30-day imaging follow-up * Willing and able to return for scheduled follow-up visits Exclusion Criteria: • Untreatable hypersensitivity to nitinol alloys (nickel and titanium)

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder heart disorder heart valve disorder tricuspid valve disorder

As listed by the trial registrant

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

Cardiovascular diseases Heart diseases Heart valve diseases Tricuspid valve disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ascension St. Vincent's Hospital

    Carmel, Indiana, 46260, United States

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