NCT02633644终止2 期
The Harmony System for the Treatment of Heart Failure Patients - A Safety and Performance Study
Enopace Biomedical5 个研究点 分布在 4 个国家目标入组 30 人开始时间: 2015年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- The occurrence of all system and/or procedure related serious adverse events
研究概览
简要总结
The purpose of the ENDO-HF study is to determine the safety & performance of the Harmony System for the treatment of heart failure
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
- •Subject is diagnosed as chronic heart failure NYHA class II-III
- •Subject should be receiving optimal medical treatment
- •Subject signed and dated informed consent
排除标准
- •Subject has severe aortic sclerosis or calcification
- •Subject diagnosed with severe aortic valve disease
- •Subject has severe mitral stenosis
- •Subject involved in any concurrent clinical investigation
- •Subject with cerebral vascular accident or transient ischemic attack prior to enrollment
- •Subject diagnosed with Marfan Syndrome
- •Subject with moderate or severe chronic obstructive lung disease
- •Subject is allergic to iodine or contrast media
- •Subject with prior cardiac transplant or heart transplant candidate
- •Subject with a life expectancy of less than 12 months
研究组 & 干预措施
Treated with Harmony System
Experimental
Implantation and activation of the Harmony endovascular neurostimulator
干预措施: Harmony System (Device)
结局指标
主要结局
The occurrence of all system and/or procedure related serious adverse events
时间窗: 6 months
次要结局
- The change in echocardiographic assessment of LV end systolic volume(6 months)
- The change in the New York Heart Association (NYHA) functional class as set by the Primary Investigator (PI)(6 months)
- The change in echocardiographic assessment of LV ejection fraction(6 months)
- The change in the exercise capacity as defined in a 6-minute walk test(6 months)
- The change in heart failure symptoms, as measured by quality of life, defined as an improvement from baseline on the Minnesota Living with Heart Failure® Questionnaire (MLWHFQ)(6 months)
- The change in echocardiographic assessment of LV end diastolic volume(6 months)
- The change in echocardiographic assessment of LV mass index(6 months)
- The change in echocardiographic assessment of left atrium volume index(6 months)
研究者
研究点 (5)
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