NCT00158925已完成不适用
The EASYTRAK EPI Clinical Investigation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Lead-related Complication-free Rate at 3 Months
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead.
详细描述
This is a prospective, single-armed, multi-center U.S., Australian, Canadian, and European clinical investigation, designed to demonstrate the safety and effectiveness of the EASYTRAK EPI lead in humans.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the EASYTRAK EPI indications
- •Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law
- •Patients who are willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol
- •Patients who meet any one of the following three conditions:
- •Meet current indications for cardiac resynchronization therapy (CRT) and epicardial placement of a pace/sense lead on the left ventricle is preferred over an endocardial lead
- •Meet current indications for a cardiac pacing system and have documented evidence that an endocardial lead cannot be used
- •Meet current indications for a cardiac pacing system and a concurrent cardiac surgical procedure is taking place where no additional surgical procedures are required to provide access to the epicardial surface of the heart
排除标准
- •Patients who meet the EASYTRAK EPI contraindications
- •Patients who have had a myocardial infarct, unstable angina, or percutaneous coronary intervention during the preceding 30 days prior to enrollment
- •Patients with a documented life expectancy of less than 6 months or expected to undergo heart transplant within the next 6 months
- •Patients enrolled in any concurrent study, without Guidant written approval, that may confound the results of this study
- •Women who are pregnant or plan to become pregnant
结局指标
主要结局
Lead-related Complication-free Rate at 3 Months
时间窗: 3 months
The estimated target value for this endpoint is 80%.
Chronic Sensing Amplitudes at 3 Months
时间窗: 3 months
The expected mean is 10mV.
Chronic Pacing Thresholds at 3 Months
时间窗: 3 months
The expected mean pacing threshold is 1.9V at 0.5 ms pulse width.
Chronic Pacing Impedances at 3 Months
时间窗: 3 months
The expected mean impedance is 500 Ohms.
次要结局
- Lead Implant Time(Implant)
研究者
研究点 (2)
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