NCT00568230已完成1 期
An Open-Label, Single-Arm Feasibility Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty (PTMA) Device Used to Reduce Mitral Regurgitation.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Viacor
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- percent of patients who remain free from device-related major adverse events (death, myocardial infarction, tamponade, emergent cardiac surgery)
研究概览
简要总结
Improvement of heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic heart failure
- •moderate to severe mitral regurgitation
- •20 - 50% LVEF
排除标准
- •mitral regurgitation of organic origins
- •recent interventions
- •severe comorbidities
结局指标
主要结局
percent of patients who remain free from device-related major adverse events (death, myocardial infarction, tamponade, emergent cardiac surgery)
时间窗: 30 days
次要结局
- percent of implanted patients who maintain a sustained 1 grade reduction in mitral regurgitation and reduction of mitral annulus anterior posterior dimension(30 days)
- improvement of clinical symptoms of heart failure as defined by percent of patients who exhibit one of the following: decrease in NYHA class, improvement in Minnesota QOL survey, increase in exercise capacity: 6 minute walk or VO2max(30 days)
研究者
研究点 (1)
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