Transcatheter Tricuspid Valve Replacement Using the Lux-Valve Plus System for Patients With No Other Interventional Option: A Compassionate Use Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- A composite endpoint of Major Adverse Event (MAE)
研究概览
简要总结
Tricuspid regurgitation (TR) is a common disease, and the tricuspid valve (TV) is no longer a "forgotten valve". Open heart surgery for isolated TR is uncommonly performed due to high operative risk (8-10% mortality). However, TR is associated with increased morbidity and mortality. There exists an unmet clinical need for less invasive intervention to treat TR. Transcatheter edge to edge repair (TEER) is a technique that is shown to be safe and effective in TR reduction and is associated with significant symptom improvement. However, a significant portion of TV anatomy are not suitable to be treated with TEER (e.g. coaptation gap >10mm). A wide variety of technologies has been developed in recent years. Transcatheter tricuspid valve replacement (TTVR) is one of the more promising option for tricuspid regurgitation (TR) patients at high risk for surgery. A previous study reported that transcatheter tricuspid devices, which were employed with the radial force between the device and tricuspid annulus, were radial force-dependent. However, this radial force for valve fixation may cause complications, such as conduction block and right coronary artery impingement. The LuX-Valve (Jenscare Biotechnology) is a radial force-independent orthotopic TTVR device. The feasibility and efficacy of this device have been reported by several studies. However, this valve was implanted through right atrial access, where a small incision of the right chest and right atrium is needed. The LuX-Valve Plus valve replacement system is the second-generation version of the LuX-Valve and can be implanted through the jugular vein. The first-in-human implantation was recently performed. The study aims to assess the feasibility, safety and efficacy outcome of the Lux Valve Plus system in a cohort of otherwise no surgical option patients with severe symptomatic tricuspid regurgitation despite optimal medical therapy.
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
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 50- to 90-year-old
- •Severe symptomatic tricuspid regurgitation (NYHA III-IV) despite optimal medical therapy
- •Deem high risk for tricuspid valve surgery determined by a multidisciplinary heart team (including cardiologists, cardiac surgeons and cardiac anesthetists)
- •Anatomically not feasible with other transcatheter tricuspid valve therapy that is commercially available in Hong Kong (i.e. TriClip System)
- •Capacity to provide informed consent
排除标准
- •Systolic pulmonary artery pressure (sPAP) > 60 mmHg assessed by echocardiography
- •Left Ventricular Ejection Fraction (LVEF) <40%
- •Evidence of intracardiac mass, thrombus or vegetation
- •Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT
- •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
- •Active peptic ulcer or active gastrointestinal (GI) bleeding precluding anticoagulation or antiplatelet therapy
- •Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.
研究组 & 干预措施
Intervention
干预措施: LuxValve PLlus (Device)
结局指标
主要结局
A composite endpoint of Major Adverse Event (MAE)
时间窗: 1 year post-op
A composite endpoint of Major Adverse Event (MAE) at 30 days post procedure: Cardiovascular Mortality, Myocardial Infarction (MI), Stroke, New onset renal failure requiring unplanned dialysis or renal replacement therapy, Severe Bleeding (includes fatal, life-threatening and extensive bleeding as defined by VARC), Non-selective tricuspid valve surgery or transcatheter re-intervention post procedure, Major cardiac structural complications, Major access site and vascular complications, New pacemaker implantation due to AV block
次要结局
- Acute Device Success Rate(At the end of Procedure)
- Procedural Success Rate(At the end of Procedure)
- All-cause mortality(30-day and 1-year post-op)
- Heart failure hospitalization(30-day and 1-year post-op)
- NYHA Functional Class(30-day and 1-year post-op)
- Distance of 6-Minute Walk Test(30-day and 1-year post-op)
- Kansas City Cardiomyopathy Questionnaire(30-day and 1-year post-op)
- TR Severity(Baseline, day 1, day 30, 6-month, 1-year)
- Mean Tricuspid valve inflow gradient(Baseline, day 1, day 30, 6-month, 1-year)
- Right Atrial Volume(Baseline, day 1, day 30, 6-month, 1-year)
- TAPSE(Baseline, day 1, day 30, 6-month, 1-year)
- Right ventricular functions assessments(Baseline, day 1, day 30, 6-month, 1-year)
- Right ventricular functions assessments: fractional area change（FAC）(Baseline, day 1, day 30, 6-month, 1-year)
- Right ventricular functions assessments: systolic tricuspid lateral annular tissue velocity S'(Baseline, day 1, day 30, 6-month, 1-year)
- Right ventricular functions assessments: Hepatic vein flow reversal(Baseline, day 1, day 30, 6-month, 1-year)
- Systolic pulmonary artery pressure(Baseline, day 1, day 30, 6-month, 1-year)
- Left Ventricular Ejection Fraction (LVEF)(Baseline, day 1, day 30, 6-month, 1-year)
- Paravalvular leak severity(Baseline, day 1, day 30, 6-month, 1-year)
研究者
Dr So Chak Yu kent
Principle Investigator
Prince of Wales Hospital, Shatin, Hong Kong