Tricuspid RegurgitationLuxValveNCT06714500
Transcatheter Tricuspid Valve Replacement Using the Lux-Valve Plus System
A study testing LuxValve PLlus in people with Tricuspid Regurgitation, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- LuxValve PLlus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Sep 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong, Shatin, 0000
Chak Yu So, 85235051518, kentso987@gmail.com
About this study
Official title: Transcatheter Tricuspid Valve Replacement Using the Lux-Valve Plus System for Patients With No Other Interventional Option: A Compassionate Use Study
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.
- Conditions
- Tricuspid Regurgitation
- Being tested
- LuxValve PLlus
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuxValve PLlusDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Device: LuxValve PLlus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year post-op
Secondary outcomes (18)
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.
Measured: 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.
Measured: At the end of Procedure
All-cause mortality
30-day and 1-year all-cause mortality
Measured: 30-day and 1-year post-op
Heart failure hospitalization
30-day and 1-year Heart failure hospitalization
Measured: 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
Measured: 30-day and 1-year post-op
Distance of 6-Minute Walk Test
Distance of 6-Minute Walk Test in meters
Measured: 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
Measured: 30-day and 1-year post-op
TR Severity
TR Severity assessed by echocardiography
Measured: Baseline, day 1, day 30, 6-month, 1-year
Mean Tricuspid valve inflow gradient
Mean Tricuspid valve inflow gradient assessed by echocardiography
Measured: Baseline, day 1, day 30, 6-month, 1-year
Right Atrial Volume
Right Atrial Volume assessed by echocardiography
Measured: Baseline, day 1, day 30, 6-month, 1-year
TAPSE
TAPSE assessed by echocardiography
Measured: Baseline, day 1, day 30, 6-month, 1-year
Right ventricular functions assessments
Right ventricular functions assessments assessed by echocardiography
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, day 1, day 30, 6-month, 1-year
Systolic pulmonary artery pressure
Systolic pulmonary artery pressure assessed by echocardiography
Measured: Baseline, day 1, day 30, 6-month, 1-year
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF) assessed by echocardiography
Measured: Baseline, day 1, day 30, 6-month, 1-year
Paravalvular leak severity
Paravalvular leak severity assessed by echocardiography
Measured: Baseline, day 1, day 30, 6-month, 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start18 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr So Chak Yu kent, Prince of Wales Hospital, Shatin, Hong Kong
- Investigators
- Kent So, PI, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714500
- Sponsor's protocol ID
- 2023.029
- Acronym
- LuxValve
- Status last verified
- Sep 2026
- First submitted
- 26 Nov 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Tricuspid Valve Replacement Using the Lux-Valve Plus System for Patients With No Other Interventional Option: A Compassionate Use Study
- ClinicalTrials.gov ID
- NCT06714500
- Acronym / sponsor ID
- LuxValve / 2023.029
- Conditions
- Tricuspid Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong KongUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: LuxValve PLlus |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LuxValve PLlusThe 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. | Device | Intervention |
Primary outcome
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
18 secondary outcomes
Acute Device Success Rate
Time frame: At the end of Procedure
Procedural Success Rate
Time frame: At the end of Procedure
All-cause mortality
Time frame: 30-day and 1-year post-op
Heart failure hospitalization
Time frame: 30-day and 1-year post-op
NYHA Functional Class
Time frame: 30-day and 1-year post-op
Distance of 6-Minute Walk Test
Time frame: 30-day and 1-year post-op
Kansas City Cardiomyopathy Questionnaire
Time frame: 30-day and 1-year post-op
TR Severity
Time frame: Baseline, day 1, day 30, 6-month, 1-year
Mean Tricuspid valve inflow gradient
Time frame: Baseline, day 1, day 30, 6-month, 1-year
Right Atrial Volume
Time frame: Baseline, day 1, day 30, 6-month, 1-year
TAPSE
Time frame: Baseline, day 1, day 30, 6-month, 1-year
Right ventricular functions assessments
Time frame: Baseline, day 1, day 30, 6-month, 1-year
Right ventricular functions assessments: fractional area change（FAC）
Time frame: Baseline, day 1, day 30, 6-month, 1-year
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: Hepatic vein flow reversal
Time frame: Baseline, day 1, day 30, 6-month, 1-year
Systolic pulmonary artery pressure
Time frame: Baseline, day 1, day 30, 6-month, 1-year
Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline, day 1, day 30, 6-month, 1-year
Paravalvular leak severity
Time frame: Baseline, day 1, day 30, 6-month, 1-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No. IPD will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kent So, PI principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LuxValve PLlus in people with Tricuspid Regurgitation, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Xu, Nursing Officer (35051518, danielxu@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite endpoint of Major Adverse Event (MAE) (time frame: 1 year post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.