Prospective Study Comparing the Sensed R Wave in Bipolar and Extended Bipolar Configurations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Duration of sensing (time to detection) in VF at the time of implant.
研究概览
简要总结
The PropR study will evaluate sensing during ventricular fibrillation (VF) in both bipolar and extended bipolar configurations, in order to evaluate if both can be used interchangeably in caring for patients. In addition, follow up evaluation of R wave amplitude over time would allow us to determine whether one configuration is more likely to be associated with change. This understanding would be important in selecting the proper configuration at the time of implant.
详细描述
Hypothesis:
Sensing in bipolar and extended bipolar configurations are the same. However, sensing in bipolar over time is more likely to decrease when compared to extended bipolar.
Objectives:
- To compare bipolar sensing and extended bipolar sensing in VF.
- Compare sensing in bipolar and extended bipolar over time.
Methods:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •age > 18 with ability to give informed consent,
- •patients who are expected to live more than one year,
- •patients with indication for defibrillator implant,
- •patients who are not pacemaker dependent,
- •patients with either ischemic or nonischemic cardiomyopathy.
排除标准
- •age < 18,
- •inability to give informed consent,
- •life expectancy less than one year,
- •pacemaker dependence, or use of preexisting lead for sensing,
- •any condition which would preclude ICD testing at the end of the implant,
- •patients who are undergoing upgrade to an ICD from a pacemaker will also be excluded,
- •patients with inherited arrhythmias or ion channel related arrhythmias will be excluded from the study.
结局指标
主要结局
Duration of sensing (time to detection) in VF at the time of implant.
时间窗: At implant
次要结局
- Sensing in sinus rhythm at one month(One month post implant)