Evaluation of Left Ventricular Pacing Vectors Use in Phrenic Nerve Stimulation Management and Left Ventricular Parameters Adjustment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LivaNova
- 入组人数
- 90
- 试验地点
- 19
- 主要终点
- Phrenic nerve stimulation measurement
研究概览
简要总结
Evaluation of three left ventricular pacing polarities effectiveness to narrow phrenic nerve stimulation.
详细描述
The primary endpoint of the study aims at demonstrating that the three left ventricular polarities in the Cardiac Resynchronisation Therapy-Defibrillator could bypass phrenic nerve stimulation at least in 90% of implants.
Success was defined as an absence of phrenic nerve stimulation (threshold > 7V) or in case of phrenic nerve stimulation occurrence (threshold < 7V), as the resolution of the phrenic nerve stimulation by reprogramming one of the 3 left ventricular pacing polarities available in the device : left ventricular tip- left ventricular ring (bipolar), left ventricular tip- right ventricular ring (pseudo-bipolar) and left ventricular ring-right ventricular coil.
Any occurrence of phrenic nerve stimulation without resolution by reprogramming was considered as a 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
- Prevention
- 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
- •Eligible for an implantation of a Cardiac Resynchronization Therapy-Defibrillator according to relevant regulations (will be only tolerated primo-implantation and upgrade)
- •Patient scheduled for implantation of a Cardiac Resynchronization Therapy-Defibrillator
- •Patient has given his informed consent
排除标准
- •Any contraindication for Implantable Cardioverter Defibrillator therapy
- •Heart transplantation or waiting for heart transplantation
- •Implanted with a ventricular assist device (VAD)
- •Inability to understand the purpose of the study or to cooperate
- •Not available for routine follow-up visits
- •Life expectancy less than 12 months
- •Age of less than 18 years and et pregnancy
- •Under guardianship
结局指标
主要结局
Phrenic nerve stimulation measurement
时间窗: The presence of phrenic nerve stimulation will be assessed at implant.
The presence of phrenic nerve stimulation at 10 Volt, using a pacing system analyzer
次要结局
未报告次要终点