Robotic Transjugular Transcatheter Tricuspid Valve Replacement

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorPrince of Wales Hospital, Shatin, Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

Rate of major adverse events: cardiovascular mortality

rate of cardiovascular mortality at 30 days post-operation

Time frame
30 day post-operation
3

Rate of major adverse events: myocardial infarction

rate of myocardial infarction at 30 days post-operation

Time frame
30 day post-operation
4

Rate of major adverse events: stroke

rate of stroke at 30 days post-operation

Time frame
30 day post-operation

Secondary outcomes

1

Device success rate

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

Time frame
intra-operation
2

Operation duration

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

Time frame
intra-operation
3

Overall Procedural Time

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

Time frame
intra-operation
4

Fluoroscopy Time

Fluoroscopy Time of primary TV implantation

Time frame
intra-operation

Other outcomes

Sponsors and contacts

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