The RELIEF Trial: REduction or eLimination of mItral rEgurgitation in Degenerative or Functional Mitral Regurgitation With the CardiAQ-Edwards™ Transcatheter Mitral Valve
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 15
- 主要终点
- Freedom from major adverse cardiac and cerebrovascular events
研究概览
简要总结
Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve
详细描述
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve with transapical and transseptal delivery systems in patients with degenerative or functional/ischemic mitral regurgitation.
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
- •NYHA ≥ II
- •Moderate/severe or severe mitral regurgitation
- •Prohibitive risk for open-heart surgery
- •Meets anatomical criteria
排除标准
- •Unsuitable anatomy
- •Need for emergent or urgent surgery
- •Prior mechanical aortic valve replacement
- •Any prior surgical or transcatheter repair (excluding balloon valvuloplasty) or replacement of the mitral valve
- •Preexisting device in the left ventricular apex
- •Clinically significant, untreated coronary artery disease
- •Limited life expectancy (< 12 months)
- •Active infection
研究组 & 干预措施
Treatment
Treatment with the CardiAQ-Edwards™ Transcatheter Mitral Valve (transapical or transseptal delivery)
干预措施: Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve (Device)
结局指标
主要结局
Freedom from major adverse cardiac and cerebrovascular events
时间窗: 30 days
MACCE; all-cause mortality, myocardial infarction, stroke, renal failure, and conversion to surgery per MVARC definitions
Freedom from individual adverse events
时间窗: 30 days
% Freedom from individual adverse events
次要结局
- New York Heart Association (NYHA) functional class(30 days, 3 months, 6 months, 12 months)
- Device success(30 days, 3 months, 6 months, 12 months)
- Procedure success(30 days, 3 months, 6 months, 12 months)
- Patient success(30 days, 3 months, 6 months, 12 months)
- Six minute walk test:(30 days, 3 months, 6 months, 12 months)
- Reduction in mitral regurgitation (MR) grade:(30 days, 3 months, 6 months, 12 months)
- Technical success(30 days, 3 months, 6 months, 12 months)