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NCT Number: NCT07516145

Robotic Transjugular Transcatheter Tricuspid Valve Replacement

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.

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Key information

Conditions

Tricuspid Regurgitation (TR) Cardiovascular Diseases Heart Diseases Heart Valve Diseases Transcatheter Valve Replacement Tricuspid Valve Insufficiency Valvular Heart Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Shatin, Hong Kong

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcatheter Tricuspid Valve Replacement

Device

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.

Primary outcomes

  1. Rate of Intraprocedural success according to TVARC

    Time frame: Intra-operation

    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

  2. Rate of major adverse events: cardiovascular mortality

    Time frame: 30 day post-operation

    rate of cardiovascular mortality at 30 days post-operation

  3. Rate of major adverse events: myocardial infarction

    Time frame: 30 day post-operation

    rate of myocardial infarction at 30 days post-operation

  4. Rate of major adverse events: stroke

    Time frame: 30 day post-operation

    rate of stroke at 30 days post-operation

  5. Rate of major adverse events: renal complication

    Time frame: 30 day post-operation

    Rate of renal complications requiring unplanned dialysis or renal replacement therapy at 30 days post-operation

  6. Rate of major adverse events: severe bleeding

    Time frame: 30 day post-operation

    rate of severe bleeding at 30 days post-operation

  7. Rate of major adverse events: nonelective Tricuspid Valve reintervention

    Time frame: 30 day post-operation

    rate of nonelective Tricuspid Valve reintervention at 30 days post-operation

  8. Rate of major adverse events: major vascular complications

    Time frame: 30 day post-operation

    rate of major vascular complications at 30 days post-operation

  9. Rate of major adverse events: major cardiac structural complications

    Time frame: 30 day post-operation

    rate of major cardiac structural complications at 30 days post-operation

  10. Rate of major adverse events: device-related pulmonary embolism

    Time frame: 30 day post-operation

    rate of device-related pulmonary embolism at 30 days post-operation

Secondary outcomes

  1. Device success rate

    Time frame: intra-operation

    Rate of Device success defined as device deployed and delivery system retrieved as intended intra-operation

  2. Operation duration

    Time frame: intra-operation

    Operation duration defined as Device at RA to Delivery system recaptured to sheath during operation

  3. Overall Procedural Time

    Time frame: intra-operation

    Overall Procedural Time defined as time used from obtaining Vascular Access to Closure

  4. Fluoroscopy Time

    Time frame: intra-operation

    Fluoroscopy Time of primary TV implantation

  5. Radiation Dose to Primary Operator

    Time frame: immediately post-operation

    Radiation Dose to Primary Operator during index valve implant procedure

  6. Rate of 30-day Clinical Success

    Time frame: 30-day post-operation

    Rate of 30-day Clinical Success according to TVARC definition at 30-day post-operation

  7. NYHA functional classification

    Time frame: 30-day post-operation

    NYHA functional classification at 30-day post-operation

  8. 6-minute walk distance

    Time frame: 30-day post-operation

    6-minute walk distance at 30-day post-operation

  9. Result of Kansas City Cardiomyopathy Questionnaire

    Time frame: 30-day post-operation

    Result of Kansas City Cardiomyopathy Questionnaire at 30-day post-operation

  10. Clinical success according to TVARC criteria at 1 year

    Time frame: 1-year post-operation

    1-year Clinical success according to TVARC criteria

  11. Device success rate

    Time frame: 1-year post-operation

    NYHA functional classification at 1-year post-operation

  12. 6-minute walk distance

    Time frame: 1-year post-operation

    6-minute walk distance at 1-year post-operation

  13. Result of Kansas City Cardiomyopathy Questionnaire

    Time frame: 1-year post-operation

    Result of Kansas City Cardiomyopathy Questionnaire at 1-year post-operation

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Xu

CONTACT

[email protected]

852 35051518

Sponsors and collaborators

Lead sponsor

Prince of Wales Hospital, Shatin, Hong Kong

Other

Collaborators

  • Jenscare Scientific

Registry information

Acronym: Robotic Lux

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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