Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy After Replacement of Tricuspid Valve With Transcatheter Device
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 228
- 试验地点
- 38
- 主要终点
- Clinical Success
研究概览
简要总结
Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System
详细描述
The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Functional or degenerative TR moderate or greater
- •Symptomatic despite medical therapy or prior HF hospitalization from TR
- •The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement
排除标准
- •Tricuspid valve anatomic contraindications
- •Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months
- •Hemodynamic instability
- •Refractory heart failure requiring advanced intervention
- •Currently participating in another investigational study in which the patient has not reached a primary endpoint
研究组 & 干预措施
Treatment
Treatment with the Edwards EVOQUE Tricuspid Valve Replacement System
干预措施: Transcatheter Tricuspid Valve Replacement (Device)
结局指标
主要结局
Clinical Success
时间窗: 30 Days
Procedural success without MAEs at 30 days.
Composite Major Adverse Events (MAEs)
时间窗: 30 Days
Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction, stroke, renal complications requiring unplanned dialysis or renal replacement therapy, severe bleeding, unplanned or emergency tricuspid valve re-intervention, major access site and vascular complications, major access site and vascular complications, and device-related pulmonary embolism at 30 days.
Device Success
时间窗: Intraprocedural
Study device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory.
Procedure Success
时间窗: Discharge (Up to 7 days post procedure)
Device success without clinically significant paravalvular leak (PVL) on a transthoracic echocardiogram (assessed by the echo core lab) at time of discharge.
Tricuspid Regurgitation Reduction
时间窗: Discharge (Up to 7 days post procedure)
Percentage of patients with at least 1 grade reduction in tricuspid regurgitation (TR) as measured by using a 5-grade classification system (mild, moderate, severe, massive, torrential). TR grade is assessed by an independent echocardiography core laboratory.
次要结局
- Tricuspid Regurgitation (TR) Grade(Baseline, 30 Days, 6 Months)
- New York Heart Association (NYHA) Functional Class(Baseline, 30 Days, 6 Months)
- Change in Six Minute Walk Test (6WMT) Distance(30 Days, 6 Months)
- Change in Quality of Life Score as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)(30 Days, 6 Months)
- Change in Quality of Life as Measured by 36-Item Short Form Health Survey (SF-36) Mental Score(30 Days, 6 Months)
- Change in Quality of Life as Measured by 36-Item Short Form Health Survey (SF-36) Physical Score(30 Days, 6 Months)
- Change in Body Weight(30 Days, 6 Months)
- Change in Left Ankle Circumference(30 Days, 6 Months)
- Change in Right Ankle Circumference(30 Days, 6 Months)
- Edema Assessment By Visit(Baseline, 30 Days, 6 Months)