The C-MIC-II Follow-Up Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 31
- 试验地点
- 10
- 主要终点
- Mortality
研究概览
简要总结
The C-MIC System is a medical device used to treat heart failure per the intended purpose which is to treat heart failure by applying an electrical micro-current to the heart.
Target patients for this study are patients who have received the device in a prior study.
详细描述
The C-MIC System is a medical device used to treat heart failure per the intended purpose which is to treat heart failure by applying an electrical micro-current to the heart. The therapy with the C-MIC System is intended to take 6 months.
The C-MIC System consists of four parts, of which three are implanted: a transvenous and an epicardial lead and a power source to which the leads are connected. Both leads have the function to transmit micro-current to the heart. A Portable User Terminal (PUT) is needed for programming and readout of the data recorded by the Implantable Microcurrent Device (IMD).
Target patients of the C-MIC System at the time of implantation and inclusion in the C-MICII Study were patients with idiopathic dilative cardiomyopathy (NYHA class III - NYHA class who have systolic left ventricular dysfunction despite adequate therapy of heart failure.
Target patients for this study are patients who have received the device in a prior study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have received a C-MIC System during the C-MIC-II Study.
- •Informed consent in writing from the patient.
排除标准
- •Patients who are unwilling or unable to participate in the study visits.
- •Vulnerable Patients.
结局指标
主要结局
Mortality
时间窗: 2 years
Rate of all cause, cardiac and device related mortality
Hospitalizations
时间窗: 2 years
Rate of all-cause, cardiac and device related hospitalizations
Adverse events
时间窗: 2 years
Overall incidence and severity of adverse events including malfunction
次要结局
- Cange in exercise ability(2 years)
- Patient related outcome(2 years)
- Change in New York Heart Association (NYHA) classification(2 years)
- Change in aerobic capacity and endurance(2 years)
- Treatment adjustment(2 Years)
- Change in cardiac performance(2 Years)