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New heart valve device aims to fix tricuspid leak without open surgery

NCT ID NCT07528326

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a new device called the TRiCares Topaz, which replaces the tricuspid heart valve without open surgery. It is for people with severe tricuspid regurgitation (a leaky valve) who still have symptoms despite medication. The study will compare this device to another approved device to see if it is safe and effective, measuring outcomes like survival, hospitalizations, and quality of life.

What this could mean

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

Active substance
TRiCares Topaz transcatheter tricuspid heart valve replacement system
What this could lead to
If successful, this could provide a less invasive treatment option for people with severe tricuspid regurgitation, potentially reducing symptoms and hospitalizations.
What could go wrong
This is a large pivotal study, but the device is still experimental. Risks include major adverse events like death, heart failure, or need for another procedure. Long-term benefits are not yet proven.

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

About 831 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Sep 2035

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.

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: * Patient is ≥ 18 years of age * Patient has severe or greater tricuspid regurgitation with symptoms despite optimal medical therapy * Patient is an appropriate candidate to undergo TTVR as determined by the Institution Heart Team Exclusion Criteria: * Patient has a tricuspid device currently in place * Patient has anatomical contraindications * Patient is in need of urgent surgery * Patient has a left ventricular ejection fraction of \< 25% * Patient has life expectancy of \< 1 year

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Conditions

The condition(s) this trial relates to.

tricuspid valve insufficiency

As listed by the trial registrant

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

Tricuspid regurgitation (TR)

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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