Tricuspid Regurgitation (TR)Robotic LuxNCT07516145
Robotic Transjugular Transcatheter Tricuspid Valve Replacement
A study testing Transcatheter tricuspid valve replacement in people with Tricuspid Regurgitation (TR) and Valvular Heart Diseases, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
Trial summary
Valvular heart disease (VHD), caused by abnormalities in heart valves, can lead to severe complications such as heart failure and death, with approximately 220 million affected patients worldwide. The prevalence of VHD continues to grow alongside the aging global population. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tricuspid Regurgitation (TR), Valvular Heart Diseases, Transcatheter Valve Replacement
- What is being tested?
- Transcatheter tricuspid valve replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteHong Kong
- Study dates
- 12 Mar 2026to 31 Mar 2028
- Phase
- Interventional
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-90
- Severe symptomatic TR
- Deem high risk for tricuspid valve surgery determined by a multidisciplinary heart team (including cardiologists, cardiac surgeons and cardiac anesthetists) and
- Anatomically feasible for transjugular transcatheter tricuspid valve replacement using the Lux-valve plus system
- Able to consent
Who cannot join
- Prior TV repair or replacement that would interfere with Lux-valve plus implantation
- severe pulmonary hypertension (pulmonary artery systolic pressure >70 mm Hg or >2/3 systemic with pulmonary vascular resistance >5 WU after vasodilator challenge)
- Pregnant or nursing patients and those who plan pregnancy during the study period. Female patients of childbearing potential must have a negative pregnancy
- Left Ventricular Ejection Fraction (LVEF) <40% or;
- Evidence of intracardiac mass, thrombus or vegetation or;
- Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT or;
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- 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 or;
- Active peptic ulcer or active gastrointestinal (GI) bleeding precluding anticoagulation or antiplatelet therapy or;
- Underwent any cardiac or non-cardiac interventional or surgical procedure within 30 days prior to the procedure or planned to have the interventional or surgical procedure within 60 days after implant procedure (e.g., cardioversion, ablation, percutaneous coronary intervention, etc);
- Recent (within 90 days prior to procedure) stroke, transient ischemic attack, or myocardial infarction;
- Life expectancy is less than 1 year;
- Current participation in another investigational drug or device study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Valvular heart disease (VHD), caused by abnormalities in heart valves, can lead to severe complications such as heart failure and death, with approximately 220 million affected patients worldwide. The prevalence of VHD continues to grow alongside the aging global population. Transcatheter heart valve interventions have emerged as minimally invasive alternatives, offering benefits like shorter recovery times and reduced discomfort. However, current manual catheter-based techniques are complex, highly dependent on clinicians' expertise, and involve significant physical risk due to prolonged exposure to X-ray radiation and cumbersome protective gear.
To address these challenges, a novel, universal intracardiac robotic system is proposed to improve precision, safety, and procedural efficiency. This system integrates a high-dexterity, load-capacity catheter instrument, a modular concentric robotic platform, and an augmented reality (AR) navigation interface. The catheter's design balances flexibility for navigating complex intracardiac paths with the rigidity needed for device deployment. The robotic platform's modular architecture enhances versatility, enabling control across various procedures and anatomical variations, while the AR system facilitates intuitive preoperative planning and real-time intraoperative guidance through multimodal image fusion.
The core innovation lies in overcoming existing limitations: balancing catheter flexibility and load capacity, expanding robotic system adaptability for different valve procedures, and improving integration with imaging modalities like computed tomography, transesophageal echocardiogram, and fluoroscopy. The project aims to develop sophisticated models for instrument design, control strategies for multi-instrument coordination, and advanced navigation tools. These technological advancements are intended to elevate the clinical utility of robotic intracardiac interventions, making them safer, more efficient, and easier to adopt widely. By establishing a systematic approach for intelligent, multimodal, robotic-assisted valvular procedures, this work promises significant contributions to minimally invasive cardiology and holds substantial potential for clinical translation.
- Being tested
- Transcatheter tricuspid valve replacement
- Keywords
- Tricuspid Regurgitation, Valvular heart diseases, Transcatheter Valve Replacement
- Medical subject headings
- Tricuspid Valve Insufficiency, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter tricuspid valve replacementDevice
Recent advancements in transcatheter therapies have demonstrated promising outcomes for patients with tricuspid valve disease, with transcatheter tricuspid valve replacement (TTVR) emerging as a viable alternative to surgical intervention. The Lux Valve Plus system represents a novel transjugular transcatheter tricuspid valve replacement platform designed to address the unique anatomical challenges of the tricuspid valve. Its transjugular design is advantageous for valve alignment; however, this access route is ergonomically unfavourable for the implanter, increasing radiation exposure compared to a transfemoral approach. Integrating robotic-assisted technology into this platform could potentially reduce radiation exposure, improve ergonomics for operators, and facilitate accurate valve delivery. This research aims to explore the feasibility of robotic transjugular TTVR using the Lux Valve Plus system.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Device: Transcatheter tricuspid valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Intraprocedural success according to TVARC
TVARC intra-procedural success is defined as:
- Absence of intraprocedural mortality or stroke; and
- Successful access, delivery, and retrieval of the device delivery system; and
- Successful deployment and correct positioning of the intended device(s) without requiring implantation of unplanned additional devices; and
- Adequate performance of the transcatheter device. Performance of devices whose purpose is a reduction in TR, should include the absence of tricuspid stenosis (TVA >1.5 cm 2 and mean gradient <5 mm Hg); reduction of total tricuspid regurgitation to optimal (<= mild) or acceptable (<=moderate).
- Absence of device-related obstruction of forward flow
- Absence of device-related pulmonary embolism
- Freedom from emergency surgery or reintervention during the first 24 h related to the device or access procedure
Measured: Intra-operation
Rate of major adverse events: cardiovascular mortality
rate of cardiovascular mortality at 30 days post-operation
Measured: 30 day post-operation
Rate of major adverse events: myocardial infarction
rate of myocardial infarction at 30 days post-operation
Measured: 30 day post-operation
Rate of major adverse events: stroke
rate of stroke at 30 days post-operation
Measured: 30 day post-operation
Rate of major adverse events: renal complication
Rate of renal complications requiring unplanned dialysis or renal replacement therapy at 30 days post-operation
Measured: 30 day post-operation
Rate of major adverse events: severe bleeding
rate of severe bleeding at 30 days post-operation
Measured: 30 day post-operation
Rate of major adverse events: nonelective Tricuspid Valve reintervention
rate of nonelective Tricuspid Valve reintervention at 30 days post-operation
Measured: 30 day post-operation
Rate of major adverse events: major vascular complications
rate of major vascular complications at 30 days post-operation
Measured: 30 day post-operation
Rate of major adverse events: major cardiac structural complications
rate of major cardiac structural complications at 30 days post-operation
Measured: 30 day post-operation
Rate of major adverse events: device-related pulmonary embolism
rate of device-related pulmonary embolism at 30 days post-operation
Measured: 30 day post-operation
Secondary outcomes (13)
Device success rate
Rate of Device success defined as device deployed and delivery system retrieved as intended intra-operation
Measured: intra-operation
Operation duration
Operation duration defined as Device at RA to Delivery system recaptured to sheath during operation
Measured: intra-operation
Overall Procedural Time
Overall Procedural Time defined as time used from obtaining Vascular Access to Closure
Measured: intra-operation
Fluoroscopy Time
Fluoroscopy Time of primary TV implantation
Measured: intra-operation
Radiation Dose to Primary Operator
Radiation Dose to Primary Operator during index valve implant procedure
Measured: immediately post-operation
Rate of 30-day Clinical Success
Rate of 30-day Clinical Success according to TVARC definition at 30-day post-operation
Measured: 30-day post-operation
NYHA functional classification
NYHA functional classification at 30-day post-operation
Measured: 30-day post-operation
6-minute walk distance
6-minute walk distance at 30-day post-operation
Measured: 30-day post-operation
Result of Kansas City Cardiomyopathy Questionnaire
Result of Kansas City Cardiomyopathy Questionnaire at 30-day post-operation. Scoring scale 0-100, higher score refers to better outcome.
Measured: 30-day post-operation
Clinical success according to TVARC criteria at 1 year
1-year Clinical success according to TVARC criteria
Measured: 1-year post-operation
Device success rate
NYHA functional classification at 1-year post-operation
Measured: 1-year post-operation
6-minute walk distance
6-minute walk distance at 1-year post-operation
Measured: 1-year post-operation
Result of Kansas City Cardiomyopathy Questionnaire
Result of Kansas City Cardiomyopathy Questionnaire at 1-year post-operation Scoring scale 0-100, higher score refers to better outcome.
Measured: 1-year post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start12 Mar 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Regurgitation (TR)Studies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Jenscare Scientific
- Responsible party
- Principal investigator, Dr So Chak Yu kent, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516145
- Sponsor's protocol ID
- 2025.473
- Acronym
- Robotic Lux
- Status last verified
- Sep 2026
- First submitted
- 31 Mar 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided