An interventional study of LuxValve PLlus in Tricuspid Regurgitation, sponsored by Prince of Wales Hospital, Shatin, Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Prince of Wales Hospital, Shatin, Hong Kong · Not applicable, Interventional, and Treatment
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.
226 studies on the registry are indexed under Tricuspid Valve Insufficiency; 109 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 128 interventional studies indexed under Tricuspid Valve Insufficiency.
Browse Tricuspid Valve Insufficiency studies →Prince of Wales Hospital, Shatin, Hong Kong is the lead sponsor of 27 studies on the registry; 15 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: LuxValve PLlus
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.
A composite endpoint of Major Adverse Event (MAE)
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
Time frame: 1 year post-op
Acute Device Success Rate
successful deployment of the device and removal of the delivery system as planned, with no unplanned surgery related to the device or access procedure.
Time frame: At the end of Procedure
Procedural Success Rate
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.
Time frame: At the end of Procedure
All-cause mortality
30-day and 1-year all-cause mortality
Time frame: 30-day and 1-year post-op
Heart failure hospitalization
30-day and 1-year Heart failure hospitalization
Time frame: 30-day and 1-year post-op
NYHA Functional Class
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
Time frame: 30-day and 1-year post-op
Distance of 6-Minute Walk Test
Distance of 6-Minute Walk Test in meters
Time frame: 30-day and 1-year post-op
Kansas City Cardiomyopathy Questionnaire
Kansas City Cardiomyopathy Questionnaire (KCCQ)：Scores are transformed to a range of 0-100, in which higher scores reflect better health status
Time frame: 30-day and 1-year post-op
TR Severity
TR Severity assessed by echocardiography
Time frame: Baseline, day 1, day 30, 6-month, 1-year
Mean Tricuspid valve inflow gradient
Mean Tricuspid valve inflow gradient assessed by echocardiography
Time frame: Baseline, day 1, day 30, 6-month, 1-year
Right Atrial Volume
Right Atrial Volume assessed by echocardiography
Time frame: Baseline, day 1, day 30, 6-month, 1-year
TAPSE
TAPSE assessed by echocardiography
Time frame: Baseline, day 1, day 30, 6-month, 1-year
Right ventricular functions assessments
Right ventricular functions assessments assessed by echocardiography
Time frame: Baseline, day 1, day 30, 6-month, 1-year
Right ventricular functions assessments: fractional area change（FAC）
Right ventricular functions assessments: fractional area change（FAC）assessed by echocardiography
Time frame: Baseline, day 1, day 30, 6-month, 1-year
Right ventricular functions assessments: systolic tricuspid lateral annular tissue velocity S'
Right ventricular functions assessments: systolic tricuspid lateral annular tissue velocity S' assessed by echocardiography
Time frame: Baseline, day 1, day 30, 6-month, 1-year
Right ventricular functions assessments: Hepatic vein flow reversal
Right ventricular functions assessments: Hepatic vein flow reversal assessed by echocardiography
Time frame: Baseline, day 1, day 30, 6-month, 1-year
Systolic pulmonary artery pressure
Systolic pulmonary artery pressure assessed by echocardiography
Time frame: Baseline, day 1, day 30, 6-month, 1-year
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF) assessed by echocardiography
Time frame: Baseline, day 1, day 30, 6-month, 1-year
Paravalvular leak severity
Paravalvular leak severity assessed by echocardiography
Time frame: Baseline, day 1, day 30, 6-month, 1-year
Plan to share: No — IPD will not be shared
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Prince of Wales Hospital, Shatin, Hong Kong