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New heart valve implant offers hope for patients too sick for surgery

NCT ID NCT06581471

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 study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new device called the TRiCares Topaz system to replace a leaky heart valve (tricuspid valve) without open-heart surgery. It will enroll 80 adults with severe leakage who are at high risk for traditional surgery. The goal is to see if the device is safe and can reduce the leak, helping patients feel better and walk farther.

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 80 people

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

Started

Aug 2024

Expected to finish

Dec 2030

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: * Adult patients * Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential) * Institutional Heart Team evaluates patient as being at increased operative risk Exclusion Criteria: * Patient in need of emergent intervention * Patient who is hemodynamically unstable * Anatomical contraindications for implantation with study device * Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder heart valve disorder tricuspid valve insufficiency

As listed by the trial registrant

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

Cardiovascular diseases Heart valve disease Tricuspid valve regurgitation

How to take part

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

  1. The places running it

    8 sites in 2 countries. 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

  • AZ Delta

    RECRUITING

    Roeselare, 8800, Belgium

  • Algemeen Stedelijk Ziekenhuis

    RECRUITING

    Aalst, 9300, Belgium

  • Centre hospitalier universitaire CHU de Liège

    NOT_YET_RECRUITING

    Liège, Belgium

  • Cliniques Universitaires Saint-Luc UCL

    RECRUITING

    Brussels, Belgium

  • Ludwig Maximilian University Hospital

    RECRUITING

    Munich, 81377, Germany

  • UZ Brussel

    RECRUITING

    Brussels, 1090, Belgium

  • University Medical Center of the Johannes Gutenberg University Mainz

    NOT_YET_RECRUITING

    Mainz, 55131, Germany

  • ZNA Middelheim

    RECRUITING

    Antwerp, Belgium

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