Robotic Transjugular Transcatheter Tricuspid Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Rate of Intraprocedural success according to TVARC
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Intervention
干预措施: Transcatheter tricuspid valve replacement (Device)
结局指标
主要结局
Rate of Intraprocedural success according to TVARC
时间窗: 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
时间窗: 30 day post-operation
rate of cardiovascular mortality at 30 days post-operation
Rate of major adverse events: myocardial infarction
时间窗: 30 day post-operation
rate of myocardial infarction at 30 days post-operation
Rate of major adverse events: stroke
时间窗: 30 day post-operation
rate of stroke at 30 days post-operation
Rate of major adverse events: renal complication
时间窗: 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
时间窗: 30 day post-operation
rate of severe bleeding at 30 days post-operation
Rate of major adverse events: nonelective Tricuspid Valve reintervention
时间窗: 30 day post-operation
rate of nonelective Tricuspid Valve reintervention at 30 days post-operation
Rate of major adverse events: major vascular complications
时间窗: 30 day post-operation
rate of major vascular complications at 30 days post-operation
Rate of major adverse events: major cardiac structural complications
时间窗: 30 day post-operation
rate of major cardiac structural complications at 30 days post-operation
Rate of major adverse events: device-related pulmonary embolism
时间窗: 30 day post-operation
rate of device-related pulmonary embolism at 30 days post-operation
次要结局
- Device success rate(intra-operation)
- Operation duration(intra-operation)
- Overall Procedural Time(intra-operation)
- Fluoroscopy Time(intra-operation)
- Radiation Dose to Primary Operator(immediately post-operation)
- Rate of 30-day Clinical Success(30-day post-operation)
- NYHA functional classification(30-day post-operation)
- 6-minute walk distance(30-day post-operation)
- Result of Kansas City Cardiomyopathy Questionnaire(30-day post-operation)
- Clinical success according to TVARC criteria at 1 year(1-year post-operation)
- Device success rate(1-year post-operation)
- 6-minute walk distance(1-year post-operation)
- Result of Kansas City Cardiomyopathy Questionnaire(1-year post-operation)
研究者
Dr So Chak Yu kent
Clinical Assistant Professor
Prince of Wales Hospital, Shatin, Hong Kong