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临床试验/jRCT2022220045
jRCT2022220045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 (TRISCEND JAPAN)

Edwards Lifesciences Japan LLC0 个研究点目标入组 45 人开始时间: 待定最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
45
主要终点
All-cause mortality
研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Single Arm Study
干预模型
Single Assignment
主要目的
Treatment Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
18age old over 至 No limit（—）
性别
All

入选标准

  • •Symptomatic Tricuspid Regurgitation (TR) despite medical therapy
  • •Tricuspid Regurgitation 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 post procedure

All-cause mortality (1-year post procedure)

Heart failure hospitalization

时间窗: 1-year post procedure

Heart failure hospitalization (1-year post procedure)

次要结局

未报告次要终点

研究者

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