NCT01789112已完成不适用
Acute Neurotrophic Effects of a Non Excitatory Cardial Stimulation by Optimizer III System in Patients With Heart Failure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- positive inotropic effects by CCM stimulation
研究概览
简要总结
Electric stimulation by cardial contractility modulation (CCM)to improve contractility and physical capacity
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •planned CCM Implantation
- •systolic left ventricular dysfunction despite of adequate therapy of heart failure (NYHA II, III, IV)
- •implanted pacemaker, defibrillator or pacemaker during CS intubation
- •written informed consent
- •open entryways
排除标准
- •anemia Hemoglobin (HB)<8 mg/dl
- •lying coronary sinus (CS) tube or CS being not able to intubate
- •chronic atrial fibrillation or flutter
- •mechanic tricuspid valve prothesis
- •no access via subclavian vein
- •patients with VVI pacemaker being stimulated 110%
- •idiopathic hypertrophic cardiomyopathy, restrictive constrictive cardiomyopathy or heart failure because of known inflammatory or infiltrative illnesses or constrictive illness
- •acute myocardial ischemia presented by angina pectoris or ECG changes under load
- •patients being hospitalized because of heart failure during the last month and have to be treated with intravenous diuretics or inotropic substances
- •acute coronary syndrome should not be implanted for at least 3 month
- •patients with mechanic aortic or tricuspid valve
- •patients after heart transplantation
- •patients with clinical significant ectopy, defined by > 8.900 PVCs during 24 hours at beginning Holter monitoring
- •patients after hypertensive crisis
- •patients with acute renal failure
- •Ejection Fraction (EF) > 35
- •patients after left ventricular pacemaker electrode
- •pregnant or breast feeding women
- •patients with heart failure after sepsis
结局指标
主要结局
positive inotropic effects by CCM stimulation
时间窗: 15 minutes
次要结局
未报告次要终点
研究者
研究点 (2)
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