NCT05760989进行中（未招募）不适用
Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System: Investigation of Safety and Clinical Efficacy Using a Novel Device in Patients With at Least Severe Tricuspid Regurgitation in JAPAN
Edwards Lifesciences10 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年2月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
- 试验地点
- 10
- 主要终点
- All-Cause Mortality
研究概览
简要总结
A prospective, open, non-randomized, multicenter, clinical trial to evaluate the safety and effectiveness of the Edwards EWJ-202 transcatheter tricuspid valve replacement system in the treatment of patients with at least severe tricuspid regurgitation despite medical therapy. Subjects will be followed at discharge, 30 days, 6 months and annually through 5 years.
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
- •Symptomatic tricuspid regurgitation (TR) despite medical therapy
- •TR graded as severe or greater
- •Appropriate for transcatheter tricuspid valve replacement per the local heart team
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
结局指标
主要结局
All-Cause Mortality
时间窗: 1 year
Participants with all-cause mortality at 1 year from the index procedure
Heart Failure Hospitalization
时间窗: 1 year
Participants with a heart failure hospitalization at 1 year from the index procedure
次要结局
- New York Heart Association (NYHA) Functional Class(30 days, 6 months, 12 months, annual for five years)
- Health Status as measured by the SF-36 Questionnaire(30 days, 6 months, 12 months, annual for five years)
- Health Status as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)(30 days, 6 months, 12 months, annual for five years)
- Rates of various adverse events(30 days, 6 months, 12 months, annual for five years)
- Rate of Major Adverse Events (MAEs)(30 days)
- Reduction in TR grade(30 days, 6 months, 12 months, annual for five years)
- Health Status as measured by the EQ-5D-5L Questionnaire(30 days, 6 months, 12 months, annual for five years)
- Six-minute walk test(30 days, 6 months, 12 months, annual for five years)
研究者
研究点 (10)
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