NCT02232984已完成不适用
Quadripolar CRT-D On Currently Approved Lead SystemS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 749
- 试验地点
- 60
- 主要终点
- Number of Vectors With Phrenic Nerve Stimulation (PNS)
研究概览
简要总结
The purpose of the study is to evaluate different ways to program around extracardiac stimulation.
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
- •Subject is medically indicated for implantation with a Boston Scientific (BSC) DYNAGEN or INOGEN X4 CRT-D (or any future FDA approved BSC X4 CRT-D) and already implanted with/scheduled to receive a commercially available quadripolar left ventricular lead
- •Subject is willing and capable of providing informed consent and participating in all testing and study visits associated with this investigation at an approved center and at the intervals defined by this protocol
- •Subject is age 18 or above, or of legal age to give informed consent specific to state and national law
排除标准
- •Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)
- •Subject is enrolled in any other concurrent study, without prior approval from BSC
- •Women of childbearing potential who are or might be pregnant at the time of study enrollment
结局指标
主要结局
Number of Vectors With Phrenic Nerve Stimulation (PNS)
时间窗: Pre-discharge (up to 7 days post implant)
The primary objective of this study was to characterize the performance of Boston Scientific (BSC) unique pacing vectors vs. BSC/St Jude Medical (STJ) common pacing vectors to prevent phrenic nerve stimulation (PNS) based on the selected pacing cathode. BSC unique vectors are those that are only available with Boston Scientific's (BSC) quadripolar (X4) CRT-Ds while common vectors are those that are available for both BSC and STJ systems.
次要结局
- Final LV Lead Impedance at Pre-discharge(Pre-discharge (up to 7 days post implant))
- Final Pacing Treshold at Pre-discharge(Pre-discharge (up to 7 days post implant))
- Final Sensing Amplitude at Pre-discharge(Pre-discharge (up to 7 days post implant))
- Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems(At time of implantation (0 to 30 days post consent signature))
研究者
研究点 (60)
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