Robotic Transjugular Transcatheter Tricuspid Valve Replacement Using the Lux Valve Plus System

What this Trial Is About

Valvular heart disease (VHD) is caused by problems with heart valves and can lead to serious issues like heart failure and death. It affects about 220 million people worldwide, especially as the population ages. Minimally invasive transcatheter heart valve treatments offer benefits like quicker recovery and less discomfort but are complex and risk exposing clinicians to X-ray radiation. This study evaluates a new robotic system designed to improve safety, precision, and efficiency in these procedures by combining a flexible yet strong catheter, a modular robotic platform, and an augmented reality navigation system. The intervention involves a robotic-assisted transjugular transcatheter tricuspid valve replacement using the Lux Valve Plus system. This device addresses anatomical challenges of the tricuspid valve and aims to reduce radiation exposure for the operator while improving valve placement accuracy. The robotic platform supports different procedures and patient anatomies, and the augmented reality system helps with planning and real-time guidance during surgery. Researchers will explore instrument design, control strategies, and navigation tools to enhance the clinical use of robotic valve interventions. Participants will undergo the robotic valve replacement procedure with ongoing monitoring of success during and after the operation. Researchers will assess various outcomes including procedural success, major adverse events within 30 days, and clinical success at 1 year. Measures like operation duration, radiation exposure, functional classification, walking ability, and quality of life questionnaires will be tracked. The study is sponsored by Prince of Wales Hospital and aims to improve minimally invasive heart valve treatments over a follow-up period extending up to one year post-operation.

Robotic Transjugular Transcatheter Tricuspid Valve Replacement