NCT00571610已完成1 期
A Single-Center, Open-Label, Single-Arm Pilot Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Implantable Device Used to Reduce Mitral Valve 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
- 5
- 试验地点
- 2
- 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
Reduction in mitral regurgitation due to safe placement of a PTMA device in the coronary sinus.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Functional MR 2+ - 4+ with left ventricular enlargement
- •Symptomatic heart failure
- •20% - 50% LVEF
排除标准
- •mitral regurgitation of organic origins
- •recent cardiac 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 MR and reduction of mitral annulus anterior posterior dimension(30 days)
- percent of implanted patients who exhibit improvement of clinical symptoms as one of the following: decrease in NYHA class, improvement of Minnesota QOL survey, increase exercise capacity 6 minute walk or improvement in VO2 max(30 days)
研究者
研究点 (2)
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