Transcatheter Valve Replacement, Tricuspid Regurgitation (TR), Valvular Heart Diseases
Conditions
Keywords
Tricuspid Regurgitation, Valvular heart diseases, Transcatheter Valve Replacement
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.
Interventions
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.
Sponsors
Prince of Wales Hospital, Shatin, Hong Kong
Jenscare Scientific
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Intraprocedural success according to TVARC | Intra-operation | 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 |
| Rate of major adverse events: cardiovascular mortality | 30 day post-operation | rate of cardiovascular mortality at 30 days post-operation |
| Rate of major adverse events: myocardial infarction | 30 day post-operation | rate of myocardial infarction at 30 days post-operation |
| Rate of major adverse events: stroke | 30 day post-operation | rate of stroke at 30 days post-operation |
| Rate of major adverse events: renal complication | 30 day post-operation | Rate of renal complications requiring unplanned dialysis or renal replacement therapy at 30 days post-operation |
| Rate of major adverse events: severe bleeding | 30 day post-operation | rate of severe bleeding at 30 days post-operation |
| Rate of major adverse events: nonelective Tricuspid Valve reintervention | 30 day post-operation | rate of nonelective Tricuspid Valve reintervention at 30 days post-operation |
| Rate of major adverse events: major vascular complications | 30 day post-operation | rate of major vascular complications at 30 days post-operation |
| Rate of major adverse events: major cardiac structural complications | 30 day post-operation | rate of major cardiac structural complications at 30 days post-operation |
| Rate of major adverse events: device-related pulmonary embolism | 30 day post-operation | rate of device-related pulmonary embolism at 30 days post-operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device success rate | intra-operation | Rate of Device success defined as device deployed and delivery system retrieved as intended intra-operation |
| Operation duration | intra-operation | Operation duration defined as Device at RA to Delivery system recaptured to sheath during operation |
| Overall Procedural Time | intra-operation | Overall Procedural Time defined as time used from obtaining Vascular Access to Closure |
| Fluoroscopy Time | intra-operation | Fluoroscopy Time of primary TV implantation |
| Radiation Dose to Primary Operator | immediately post-operation | Radiation Dose to Primary Operator during index valve implant procedure |
| Rate of 30-day Clinical Success | 30-day post-operation | Rate of 30-day Clinical Success according to TVARC definition at 30-day post-operation |
| NYHA functional classification | 30-day post-operation | NYHA functional classification at 30-day post-operation |
| 6-minute walk distance | 30-day post-operation | 6-minute walk distance at 30-day post-operation |
| Result of Kansas City Cardiomyopathy Questionnaire | 30-day post-operation | Result of Kansas City Cardiomyopathy Questionnaire at 30-day post-operation |
| Clinical success according to TVARC criteria at 1 year | 1-year post-operation | 1-year Clinical success according to TVARC criteria |
Countries
Hong Kong
Contacts
CONTACTDaniel Xu
Outcome results
None listed