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New artificial heart valve could help patients too sick for surgery

NCT ID NCT07705594

Disease control Sponsor: Jenscare Scientific 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This trial tests a new artificial valve, called LuX-Valve Plus, for people with severe tricuspid regurgitation (a leaky heart valve) who are not candidates for open-heart surgery. Participants are randomly assigned to receive either the valve implant plus standard medical therapy or standard therapy alone. The study measures whether the valve can reduce leak severity, improve symptoms, and avoid serious complications.

What this could mean

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

Active substance
a transvenous artificial tricuspid valve system called LuX-Valve Plus
What this could lead to
If successful, this could offer a new treatment option for people with severe tricuspid regurgitation who are too high-risk for surgery.
What could go wrong
This is an early-stage trial with a small number of participants, so results may not apply to everyone. There are risks of serious complications like stroke, bleeding, or device-related problems.

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

126 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Aug 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

65 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: * Age ≥ 65 years * Severe or greater TR (TR ≥ 3+ / 4+ by echocardiography) * High surgical risk or inoperable per heart team (TRI-SCORE ≥6, STS ≥8%, EuroSCORE II ≥3%, etc.) AND symptomatic despite GDMT (≥1 month diuretics, stable regimen for ≥2 weeks) * Suitable for TTVR per heart team * NYHA III-IV * Signed ICF and willing to comply with follow-up Exclusion Criteria: * Anatomy unsuitable for device procedure * LVEF \< 50% * SPAP \> 60 mmHg by TTE (unless RHC confirms ≤60 mmHg) * Aortic/mitral/pulmonary valve disease requiring surgery * Prosthetic valve replacement within 6 months or moderate/severe dysfunction * Ebstein anomaly or RV dysplasia * RVOT obstruction or intracardiac mass * Active endocarditis within 90 days, or antibiotics for infection within 14 days * CV/cardiac/cervical surgery within 30 days * Stroke within 90 days * Unable to tolerate anticoagulation/antiplatelet therapy * eGFR \< 30 mL/min/1.73m² or on RRT * MELD-Albumin ≥ 12 * Severe respiratory dysfunction (unsuitable for general anesthesia) * Active GI bleeding/ulcer within 90 days * Cardiogenic shock or hemodynamic instability within 30 days * Untreated severe CAD or ACS within 30 days * Life expectancy ≤ 1 year * Known allergy to device components or study drugs * Pregnancy or lactation (or planned pregnancy) * Enrolled in another interventional trial (not reached primary endpoint) * Other conditions deemed unsuitable per investigator

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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)

Contacts and locations

Locations

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032, China

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