NCT07516145

Robotic Transjugular Transcatheter Tricuspid Valve Replacement

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Prince of Wales Hospital, Shatin, Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-12
• Primary completion: 2027-09-30
• Completion: 2028-03-31
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: Hong Kong