An interventional study of Transcatheter tricuspid valve replacement in Tricuspid Regurgitation (TR), Valvular Heart Diseases and Transcatheter Valve Replacement, sponsored by Prince of Wales Hospital, Shatin, Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Prince of Wales Hospital, Shatin, Hong Kong · Not applicable, Interventional, and Treatment
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.
226 studies on the registry are indexed under Tricuspid Valve Insufficiency; 109 are open to participants now.
This study's planned enrollment of 10 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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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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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 “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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: Transcatheter tricuspid valve replacement
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.
Rate of Intraprocedural success according to TVARC
TVARC intra-procedural success is defined as: 1. Absence of intraprocedural mortality or stroke; and 2. Successful access, delivery, and retrieval of the device delivery system; and 3. Successful deployment and correct positioning of the intended device(s) without requiring implantation of unplanned additional devices; and 4. 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). 5. Absence of device-related obstruction of forward flow 6. Absence of device-related pulmonary embolism 7. Freedom from emergency surgery or reintervention during the first 24 h related to the device or access procedure
Time frame: Intra-operation
Rate of major adverse events: cardiovascular mortality
rate of cardiovascular mortality at 30 days post-operation
Time frame: 30 day post-operation
Rate of major adverse events: myocardial infarction
rate of myocardial infarction at 30 days post-operation
Time frame: 30 day post-operation
Rate of major adverse events: stroke
rate of stroke at 30 days post-operation
Time frame: 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
Time frame: 30 day post-operation
Rate of major adverse events: severe bleeding
rate of severe bleeding at 30 days post-operation
Time frame: 30 day post-operation
Rate of major adverse events: nonelective Tricuspid Valve reintervention
rate of nonelective Tricuspid Valve reintervention at 30 days post-operation
Time frame: 30 day post-operation
Rate of major adverse events: major vascular complications
rate of major vascular complications at 30 days post-operation
Time frame: 30 day post-operation
Rate of major adverse events: major cardiac structural complications
rate of major cardiac structural complications at 30 days post-operation
Time frame: 30 day post-operation
Rate of major adverse events: device-related pulmonary embolism
rate of device-related pulmonary embolism at 30 days post-operation
Time frame: 30 day post-operation
Device success rate
Rate of Device success defined as device deployed and delivery system retrieved as intended intra-operation
Time frame: intra-operation
Operation duration
Operation duration defined as Device at RA to Delivery system recaptured to sheath during operation
Time frame: intra-operation
Overall Procedural Time
Overall Procedural Time defined as time used from obtaining Vascular Access to Closure
Time frame: intra-operation
Fluoroscopy Time
Fluoroscopy Time of primary TV implantation
Time frame: intra-operation
Radiation Dose to Primary Operator
Radiation Dose to Primary Operator during index valve implant procedure
Time frame: immediately post-operation
Rate of 30-day Clinical Success
Rate of 30-day Clinical Success according to TVARC definition at 30-day post-operation
Time frame: 30-day post-operation
NYHA functional classification
NYHA functional classification at 30-day post-operation
Time frame: 30-day post-operation
6-minute walk distance
6-minute walk distance at 30-day post-operation
Time frame: 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.
Time frame: 30-day post-operation
Clinical success according to TVARC criteria at 1 year
1-year Clinical success according to TVARC criteria
Time frame: 1-year post-operation
Device success rate
NYHA functional classification at 1-year post-operation
Time frame: 1-year post-operation
6-minute walk distance
6-minute walk distance at 1-year post-operation
Time frame: 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.
Time frame: 1-year post-operation
Plan to share: Undecided
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Prince of Wales Hospital, Shatin, Hong Kong