Robotic Transjugular Transcatheter Tricuspid Valve Replacement

Обзор

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Rate of Intraprocedural success according to TVARC [Срок оценки: Intra-operation]
• Rate of major adverse events: cardiovascular mortality [Срок оценки: 30 day post-operation]
• Rate of major adverse events: myocardial infarction [Срок оценки: 30 day post-operation]
• Rate of major adverse events: stroke [Срок оценки: 30 day post-operation]
• Rate of major adverse events: renal complication [Срок оценки: 30 day post-operation]
• Rate of major adverse events: severe bleeding [Срок оценки: 30 day post-operation]
• Rate of major adverse events: nonelective Tricuspid Valve reintervention [Срок оценки: 30 day post-operation]
• Rate of major adverse events: major vascular complications [Срок оценки: 30 day post-operation]
• Rate of major adverse events: major cardiac structural complications [Срок оценки: 30 day post-operation]
• Rate of major adverse events: device-related pulmonary embolism [Срок оценки: 30 day post-operation]

Вторичные конечные точки (12)

• Device success rate [Срок оценки: intra-operation]
• Operation duration [Срок оценки: intra-operation]
• Overall Procedural Time [Срок оценки: intra-operation]
• Fluoroscopy Time [Срок оценки: intra-operation]
• Radiation Dose to Primary Operator [Срок оценки: immediately post-operation]
• Rate of 30-day Clinical Success [Срок оценки: 30-day post-operation]
• NYHA functional classification [Срок оценки: 30-day post-operation]
• 6-minute walk distance [Срок оценки: 30-day post-operation]
• Result of Kansas City Cardiomyopathy Questionnaire [Срок оценки: 30-day post-operation]
• Clinical success according to TVARC criteria at 1 year [Срок оценки: 1-year post-operation]
• Device success rate [Срок оценки: 1-year post-operation]
• 6-minute walk distance [Срок оценки: 1-year post-operation]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• Prince of Wales Hospital — Shatin

Идентификаторы

NCT: NCT07516145 · 2025.473

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗