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

NCT ID NCT07687485

Disease control Sponsor: Laplace Interventional, Inc 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 07, 2026 · Last updated Jul 23, 2026 · Updated 3 times

Summary

This study tests a new device called the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System for people with severe tricuspid regurgitation, a condition where the heart's tricuspid valve leaks blood backward. The device is placed through a catheter, avoiding open-heart surgery. The trial includes up to 700 participants with severe symptoms despite medical therapy, and compares the Laplace system to another approved device. The goal is to see if the new device is safe and improves quality of life and heart function.

What this could mean

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

Active substance
Laplace Transcatheter Tricuspid Valve Replacement System
What this could lead to
If successful, this could offer a less invasive treatment option for people with severe tricuspid regurgitation, potentially reducing symptoms and hospitalizations.
What could go wrong
This is an early study of a new device, so its safety and effectiveness are not yet proven. Risks include complications from the procedure, device failure, or no improvement in symptoms.

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 700 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2038

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 to 90 years

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 - 90 years of age at the time of the study procedure. * Symptomatic TR despite being adequately treated with OMT by the Local Heart Team for at least 30 days prior to the time of study consent. * Severe, massive or torrential tricuspid regurgitation determined by qualifying echocardiogram using the 5-grade classification. * Candidate felt suitable for transcatheter tricuspid valve replacement as determined by the local Heart Team and confirmed by the patient selection committee. * Subject has provided informed consent and agrees to return for all required post-procedure follow-up visits. * Anatomically suitable for the Laplace TTVR system. Exclusion Criteria: * Estimated life expectancy of less than 12 months. * Need for emergent, urgent or planned surgery or intervention within 30 days following the study procedure. Planned or scheduled cardiac surgery within next 12 months. * Severe renal insufficiency defined as eGFR \<25 mL/min or requiring chronic renal replacement therapy at the time of screening committee review. * Current history (within last 5 years) of illicit drug use. * Stroke or other major cerebrovascular event within 90-days prior to index procedure. * Current or planned pregnancy within next 12 months for women of childbearing potential. * Participation in another pre-market investigational device study or investigational drug study for a cardiac related drug. * Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements. Any patient considered to be vulnerable. * Anatomically unsuitable for the Laplace TTVR System

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder heart valve disorder tricuspid valve disorder tricuspid valve insufficiency

As listed by the trial registrant

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

Cardiovascular diseases (CVD) Heart valve diseases Severe heart valve disease Severe tricuspid valve regurgitation Symptomatic tricuspid regurgitation Tricuspid valve disease Tricuspid valve insufficiency Tricuspid valve regurgitation

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  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

Study contacts

  • Contact

    Email: •••••@•••••

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