NCT00572091已完成1 期
An Open-Label, Single-Arm Pilot Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty 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
- 4
- 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
Improvement in 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic heart failure
- •functional MR 2+ - 4+
- •LVEF 20% - 50%
排除标准
- •MR of organic origins
- •significant co-morbidities
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 in mitral anterior posterior dimension(30 days)
- improvement of clinical symptoms of heart failure as defined by percent of implanted patients who exhibit one of the following: decrease in NYHA class, improvement in Minnesota QOL survey, increase in 6 minute walk, improvement in VO2 max.(30 days)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral RegurgitationHeart FailureMitral RegurgitationNCT00568230Viacor12
暂停
2 期
Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure PatientsHeart FailureMitral RegurgitationNCT00787293Viacor30
暂停
2 期
Safety and Efficacy Study of the PTMA Device to Reduce Mitral Valve Regurgitation in Patients With Heart FailureHeart FailureMitral RegurgitationNCT00815386Viacor20
已完成
1 期
Montreal Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty DeviceHeart FailureMitral RegurgitationNCT00571610Viacor5
已完成
1 期
ALLEVIATE-HF-HD StudyHeart FailureNCT05501652Alleviant Medical, Inc.5