Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06714500

Transcatheter Tricuspid Valve Replacement Using the Lux-Valve Plus System

Tricuspid regurgitation (TR) is a common disease, and the tricuspid valve (TV) is no longer a "forgotten valve". Open heart surgery for isolated TR is uncommonly performed due to high operative risk (8-10% mortality). However, TR is associated with increased morbidity and mortality. There exists an unmet clinical need for less invasive intervention to treat TR. Transcatheter edge to edge repair (TEER) is a technique that is shown to be safe and effective in TR reduction and is associated with significant symptom improvement. However, a significant portion of TV anatomy are not suitable to be treated with TEER (e.g. coaptation gap >10mm). A wide variety of technologies has been developed in recent years. Transcatheter tricuspid valve replacement (TTVR) is one of the more promising option for tricuspid regurgitation (TR) patients at high risk for surgery. A previous study reported that transcatheter tricuspid devices, which were employed with the radial force between the device and tricuspid annulus, were radial force-dependent. However, this radial force for valve fixation may cause complications, such as conduction block and right coronary artery impingement. The LuX-Valve (Jenscare Biotechnology) is a radial force-independent orthotopic TTVR device. The feasibility and efficacy of this device have been reported by several studies. However, this valve was implanted through right atrial access, where a small incision of the right chest and right atrium is needed. The LuX-Valve Plus valve replacement system is the second-generation version of the LuX-Valve and can be implanted through the jugular vein. The first-in-human implantation was recently performed. The study aims to assess the feasibility, safety and efficacy outcome of the Lux Valve Plus system in a cohort of otherwise no surgical option patients with severe symptomatic tricuspid regurgitation despite optimal medical therapy.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Tricuspid Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Hong Kong, Shatin, 0000

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

LuxValve PLlus

Device

The LuX-Valve (Jenscare Biotechnology) is a radial force-independent orthotopic TTVR device. The feasibility and efficacy of this device have been reported by several studies (11-13). However, this valve was implanted through right atrial access, where a small incision of the right chest and right atrium is needed. The LuX-Valve Plus valve replacement system is the second-generation version of the LuX-Valve and can be implanted through the jugular vein.

Primary outcomes

  1. A composite endpoint of Major Adverse Event (MAE)

    Time frame: 1 year post-op

    A composite endpoint of Major Adverse Event (MAE) at 30 days post procedure: Cardiovascular Mortality, Myocardial Infarction (MI), Stroke, New onset renal failure requiring unplanned dialysis or renal replacement therapy, Severe Bleeding (includes fatal, life-threatening and extensive bleeding as defined by VARC), Non-selective tricuspid valve surgery or transcatheter re-intervention post procedure, Major cardiac structural complications, Major access site and vascular complications, New pacemaker implantation due to AV block

Secondary outcomes

  1. Acute Device Success Rate

    Time frame: At the end of Procedure

    successful deployment of the device and removal of the delivery system as planned, with no unplanned surgery related to the device or access procedure.

  2. Procedural Success Rate

    Time frame: At the end of Procedure

    Device success without clinically significant PVL, as determined by the Echo Core Lab (ECL) assessment of a discharge TTE. Subjects who die or undergo tricuspid valve surgery before discharge are procedure failures.

  3. All-cause mortality

    Time frame: 30-day and 1-year post-op

    30-day and 1-year all-cause mortality

  4. Heart failure hospitalization

    Time frame: 30-day and 1-year post-op

    30-day and 1-year Heart failure hospitalization

  5. NYHA Functional Class

    Time frame: 30-day and 1-year post-op

    NYHA Functional Class 2. Distance of 6-Minute Walk Test (6MWT) 3. Kansas City Cardiomyopathy Questionnaire (KCCQ)：Scores are transformed to a range of 0-100, in which higher scores reflect better health status

  6. Distance of 6-Minute Walk Test

    Time frame: 30-day and 1-year post-op

    Distance of 6-Minute Walk Test in meters

  7. Kansas City Cardiomyopathy Questionnaire

    Time frame: 30-day and 1-year post-op

    Kansas City Cardiomyopathy Questionnaire (KCCQ)：Scores are transformed to a range of 0-100, in which higher scores reflect better health status

  8. TR Severity

    Time frame: Baseline, day 1, day 30, 6-month, 1-year

    TR Severity assessed by echocardiography

  9. Mean Tricuspid valve inflow gradient

    Time frame: Baseline, day 1, day 30, 6-month, 1-year

    Mean Tricuspid valve inflow gradient assessed by echocardiography

  10. Right Atrial Volume

    Time frame: Baseline, day 1, day 30, 6-month, 1-year

    Right Atrial Volume assessed by echocardiography

  11. TAPSE

    Time frame: Baseline, day 1, day 30, 6-month, 1-year

    TAPSE assessed by echocardiography

  12. Right ventricular functions assessments

    Time frame: Baseline, day 1, day 30, 6-month, 1-year

    Right ventricular functions assessments assessed by echocardiography

  13. Right ventricular functions assessments: fractional area change（FAC）

    Time frame: Baseline, day 1, day 30, 6-month, 1-year

    Right ventricular functions assessments: fractional area change（FAC）assessed by echocardiography

  14. Right ventricular functions assessments: systolic tricuspid lateral annular tissue velocity S'

    Time frame: Baseline, day 1, day 30, 6-month, 1-year

    Right ventricular functions assessments: systolic tricuspid lateral annular tissue velocity S' assessed by echocardiography

  15. Right ventricular functions assessments: Hepatic vein flow reversal

    Time frame: Baseline, day 1, day 30, 6-month, 1-year

    Right ventricular functions assessments: Hepatic vein flow reversal assessed by echocardiography

  16. Systolic pulmonary artery pressure

    Time frame: Baseline, day 1, day 30, 6-month, 1-year

    Systolic pulmonary artery pressure assessed by echocardiography

  17. Left Ventricular Ejection Fraction (LVEF)

    Time frame: Baseline, day 1, day 30, 6-month, 1-year

    Left Ventricular Ejection Fraction (LVEF) assessed by echocardiography

  18. Paravalvular leak severity

    Time frame: Baseline, day 1, day 30, 6-month, 1-year

    Paravalvular leak severity assessed by echocardiography

Sponsors and collaborators

Lead sponsor

Prince of Wales Hospital, Shatin, Hong Kong

Other

Registry information

Official study title

Transcatheter Tricuspid Valve Replacement Using the Lux-Valve Plus System for Patients With No Other Interventional Option: A Compassionate Use Study

Acronym: LuxValve

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Dec 3, 2024
Registry last updated
Dec 3, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.