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Jugular vein approach tested for replacing leaky heart valve without open surgery

NCT ID NCT06714500

Symptom relief Sponsor: Prince of Wales Hospital, Shatin, Hong Kong 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Tricuspid regurgitation happens when the heart's tricuspid valve leaks, letting blood flow backward. Open heart surgery to fix it carries high risks, and some people are not eligible for other catheter-based repairs. This study tests the Lux-Valve Plus, a replacement valve delivered through the jugular vein, in patients with severe symptoms who have no other interventional options. Researchers will track major adverse events at 30 days and measure how well the device works.

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 transcatheter tricuspid valve replacement system
What this could lead to
If it works, this could offer a less invasive treatment option for people with severe tricuspid regurgitation who are too high risk for open heart surgery and not eligible for other catheter-based repairs.
What could go wrong
This is a small compassionate use study with no control group, so it cannot prove the device works better than other approaches. The procedure carries risks including bleeding, stroke, kidney failure, and need for a pacemaker.

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 20 people

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

Started

Sep 2023

Expected to finish

Jun 2027

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

50 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: * Patients aged 50- to 90-year-old * Severe symptomatic tricuspid regurgitation (NYHA III-IV) despite optimal medical therapy * Deem high risk for tricuspid valve surgery determined by a multidisciplinary heart team (including cardiologists, cardiac surgeons and cardiac anesthetists) * Anatomically not feasible with other transcatheter tricuspid valve therapy that is commercially available in Hong Kong (i.e. TriClip System) * Capacity to provide informed consent Exclusion Criteria: * Systolic pulmonary artery pressure (sPAP) \> 60 mmHg assessed by echocardiography * Left Ventricular Ejection Fraction (LVEF) \<40% * Evidence of intracardiac mass, thrombus or vegetation * Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT * 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 * Active peptic ulcer or active gastrointestinal (GI) bleeding precluding anticoagulation or antiplatelet therapy * Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.

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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

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

    Hong Kong, Shatin, 0000, Hong Kong

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