Robotic Transjugular Transcatheter Tricuspid Valve Replacement (Robotic Lux)

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.

Study Overview

• Status: Recruiting
• Conditions: Transcatheter Valve Replacement; Valvular Heart Diseases; Tricuspid Regurgitation (TR)
• Intervention / Treatment: Device: Transcatheter tricuspid valve replacement

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Xu; Phone Number: 852 35051518; Email: xjldaniel@gmail.com

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Recruiting
    • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Intra-operation
Rate of major adverse events: cardiovascular mortality	rate of cardiovascular mortality at 30 days post-operation	30 day post-operation
Rate of major adverse events: myocardial infarction	rate of myocardial infarction at 30 days post-operation	30 day post-operation
Rate of major adverse events: stroke	rate of stroke at 30 days post-operation	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	30 day post-operation
Rate of major adverse events: severe bleeding	rate of severe bleeding at 30 days post-operation	30 day post-operation
Rate of major adverse events: nonelective Tricuspid Valve reintervention	rate of nonelective Tricuspid Valve reintervention at 30 days post-operation	30 day post-operation
Rate of major adverse events: major vascular complications	rate of major vascular complications at 30 days post-operation	30 day post-operation
Rate of major adverse events: major cardiac structural complications	rate of major cardiac structural complications at 30 days post-operation	30 day post-operation
Rate of major adverse events: device-related pulmonary embolism	rate of device-related pulmonary embolism at 30 days post-operation	30 day post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device success rate	Rate of Device success defined as device deployed and delivery system retrieved as intended intra-operation	intra-operation
Operation duration	Operation duration defined as Device at RA to Delivery system recaptured to sheath during operation	intra-operation
Overall Procedural Time	Overall Procedural Time defined as time used from obtaining Vascular Access to Closure	intra-operation
Fluoroscopy Time	Fluoroscopy Time of primary TV implantation	intra-operation
Radiation Dose to Primary Operator	Radiation Dose to Primary Operator during index valve implant procedure	immediately post-operation
Rate of 30-day Clinical Success	Rate of 30-day Clinical Success according to TVARC definition at 30-day post-operation	30-day post-operation
NYHA functional classification	NYHA functional classification at 30-day post-operation	30-day post-operation
6-minute walk distance	6-minute walk distance at 30-day post-operation	30-day post-operation
Result of Kansas City Cardiomyopathy Questionnaire	Result of Kansas City Cardiomyopathy Questionnaire at 30-day post-operation	30-day post-operation
Clinical success according to TVARC criteria at 1 year	1-year Clinical success according to TVARC criteria	1-year post-operation
Device success rate	NYHA functional classification at 1-year post-operation	1-year post-operation
6-minute walk distance	6-minute walk distance at 1-year post-operation	1-year post-operation
Result of Kansas City Cardiomyopathy Questionnaire	Result of Kansas City Cardiomyopathy Questionnaire at 1-year post-operation	1-year post-operation

Collaborators and Investigators

• Sponsor: Prince of Wales Hospital, Shatin, Hong Kong
• Collaborators: Jenscare Scientific

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Tricuspid Regurgitation; Transcatheter Valve Replacement; Valvular heart diseases
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Tricuspid Valve Insufficiency; Heart Valve Diseases
• Other Study ID Numbers: 2025.473

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No