The Effect of Low LEVel TrAgus STimulation on the Electrophysiological Substrate of Patients With Ischemic CardioMyopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Repolarization alternans, an ECG measure for susceptibility to VT/VF
研究概览
简要总结
Patients with ischemic cardiomyopathy (left ventricular ejection fraction <35%) and heart failure who already have an implantable device with an atrial lead (dual chamber defibrillator or biventricular defibrillator) will undergo sequentially 1. Sham low level tragus stimulation (LLTS) (5min), 2. Active LLTS at 5Hz (15min) and 20Hz (15min) and 3. Active LLTS group with atrial pacing at 100bpm at 5Hz (15min) and 20Hz (15min). The latter is required to examine the effect of LLTS on RA independent of heart rate. Repolarization alternans will be measured by analyzing a regular 12-lead ECG using a custom-made software.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic cardiomyopathy (LVEF <35%) and heart failure
- •Implantable device with an atrial lead (dual chamber ICD or CRT-D)
- •Sinus rhythm at the time of the study
排除标准
- •Recent (<6 months) stroke or myocardial infarction
- •Persistent atrial fibrillation
- •Recurrent vaso-vagal syncopal episodes
- •Unilateral or bilateral vagotomy
- •Pregnancy or breast feeding
- •Uncontrolled diabetes or hypertension
- •Sick sinus syndrome and 2nd or 3rd degree AV block (without a pacemaker)
- •Bifascicular block or prolonged first degree block
- •Hypotension due to autonomic dysfunction
- •Inability or unwillingness to understand and/or sign informed consent
结局指标
主要结局
Repolarization alternans, an ECG measure for susceptibility to VT/VF
时间窗: during acute stimulation procedure
Repolarization alternans will be measured by analyzing a regular 12-lead ECG using a custom-made software
次要结局
未报告次要终点