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NCT Number: NCT07705594

LuX-Valve Plus System for Severe or Greater Tricuspid Regurgitation

This clinical trial aims to evaluate the safety and effectiveness of the Transvenous Artificial Tricuspid Valve System, LuX-Valve Plus System, Jenscare Scientific Co., Ltd. The study population consists of high-risk patients with severe or greater tricuspid regurgitation (TR) who are ineligible for surgical intervention and have demonstrated inadequate response to optimized medical therapy (OMT).

This is a prospective, multicenter, randomized controlled trial. A total of 111 subjects who meet all inclusion criteria and none of the exclusion criteria will be enrolled. Participants will be randomized in a 2:1 ratio to one of the following groups:

Treatment Group: Transvenous Artificial Tricuspid Valve System implantation + OMT Control Group: OMT alone

All subjects will undergo serial follow-up assessments pre-treatment, during the treatment period, and post-procedure at 30 days, 3 months, 6 months, 1 year, and annually through 2-5 years. A summary report will be submitted to the regulatory authority at the 6-month time point.

Subjects in the treatment group will have one extra follow-up visit at 7 days ± 3 days post-procedure or prior to discharge (whichever occurs first).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Tricuspid Regurgitation (TR) Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transvenous Tricuspid Valve System implantation + OMT

Device

Transvenous tricuspid valve replacement with Lux-Valve Plus System in patients with severe or greater Tricuspid Regurgitation despite optimal medical therapy (OMT)

OMT

Drug

Optimal medical therapy (OMT) as the control group for patients with severe or greater tricuspid regurgitation

Primary outcomes

  1. Incidence rate of composite endpoint events

    Time frame: 6 months post-treatment

    Percentage (%) of participants achieving composite clinical success at 6 months. Composite clinical success is defined as meeting all of the following criteria:

    • Alive;
    • No heart failure rehospitalization;
    • Reduction in tricuspid regurgitation severity by ≥1 grade from baseline;
    • Improvement in New York Heart Association (NYHA) functional class by ≥1 class from baseline.

  2. Rate of Major Adverse Events (MAE)

    Time frame: 30 Day Post-treatment

    The major adverse event (MAE) rate is defined as the occurrence of any of the following:

    Cardiac death

    Myocardial infarction

    Stroke

    New-onset renal failure requiring renal replacement therapy after the procedure

    Major bleeding (Grade ≥3b according to TVARC)

    Tricuspid valve re-intervention

    Device puncture site and vascular access complications

    Major cardiac structural complications

    Device-related pulmonary embolism

    Arrhythmia or conduction block requiring permanent pacemaker implantation

Sponsors and collaborators

Lead sponsor

Jenscare Scientific

Industry

Registry information

Official study title

A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of a Transvenous Artificial Tricuspid Valve System in Patients With Severe or Greater Tricuspid Regurgitation

Important dates

Study start
2024
Primary completion
2026
Study completion
2030
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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