Robotic Transjugular Transcatheter Tricuspid Valve Replacement

NCT07516145 | Recruiting DMC

• 1 other identifier: 2025.473
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Tricuspid Regurgitation (TR); Valvular Heart Diseases; Transcatheter Valve Replacement

Keywords

Tricuspid Regurgitation; Valvular heart diseases; Transcatheter Valve Replacement

Outcome Measures

Primary Outcomes (10)

• 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

  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 Outcomes (13)

• Device success rate

  intra-operation

• Operation duration

  intra-operation

• Overall Procedural Time

  intra-operation

• Fluoroscopy Time

  intra-operation

• Radiation Dose to Primary Operator

  immediately post-operation

Study Arms (1)

Intervention

EXPERIMENTAL

Device: Transcatheter tricuspid valve replacement

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prince of Wales Hospital, Shatin, Hong Kong: lead
• Jenscare Scientific: collaborator

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Daniel Xu

CONTACT

852 35051518; xjldaniel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start: March 12, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: September 18, 2026

Record last verified: 2026-09

Locations

HK (1)