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Robots take on tricuspid valve repair in tiny early trial

NCT ID NCT07516145

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This early study tests a robotic catheter system to replace the tricuspid valve in 10 patients with severe leakage (regurgitation) who are too high-risk for open surgery. The robot aims to improve precision and safety while reducing radiation exposure for doctors. The main goal is to see if the procedure can be done successfully without major complications.

What this could mean

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

Active substance
Lux-Valve Plus system (transcatheter tricuspid valve replacement device) delivered via a robotic catheter
What this could lead to
If successful, this could make tricuspid valve replacement safer and more precise, reducing recovery time and radiation exposure for patients.
What could go wrong
This is a very early, small trial with only 10 participants. The robotic system is new and unproven; risks include procedural failure, bleeding, stroke, or device complications.

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 10 people

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

Started

Mar 2026

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Age 18-90 * Severe symptomatic TR * Deem high risk for tricuspid valve surgery determined by a multidisciplinary heart team (including cardiologists, cardiac surgeons and cardiac anesthetists) and * Anatomically feasible for transjugular transcatheter tricuspid valve replacement using the Lux-valve plus system * Able to consent Exclusion Criteria: * Prior TV repair or replacement that would interfere with Lux-valve plus implantation * severe pulmonary hypertension (pulmonary artery systolic pressure \>70 mm Hg or \>2/3 systemic with pulmonary vascular resistance \>5 WU after vasodilator challenge) * Pregnant or nursing patients and those who plan pregnancy during the study period. Female patients of childbearing potential must have a negative pregnancy * Left Ventricular Ejection Fraction (LVEF) \<40% or; * Evidence of intracardiac mass, thrombus or vegetation or; * Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT or; * Surgical correction is indicated for other concomitant valvular disease (e.g., severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation); Subjects with concomitant valvular disease may treat their respective valve first and wait 2 months before being reassessed for the trial. * Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure or; * Active peptic ulcer or active gastrointestinal (GI) bleeding precluding anticoagulation or antiplatelet therapy or; * Underwent any cardiac or non-cardiac interventional or surgical procedure within 30 days prior to the procedure or planned to have the interventional or surgical procedure within 60 days after implant procedure (e.g., cardioversion, ablation, percutaneous coronary intervention, etc); * Recent (within 90 days prior to procedure) stroke, transient ischemic attack, or myocardial infarction; * Life expectancy is less than 1 year; * Current participation in another investigational drug or device study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Prince of Wales Hospital

    RECRUITING

    Shatin, Hong Kong

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