NCT00384722已完成2 期
EASYTRAK® 3 Downsize Lead Clinical Investigation
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Lead-related complication-free rate at one-month
研究概览
简要总结
The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 3 Downsize Lead.
详细描述
This is a prospective, non-randomized, multi-center US clinical investigation, designed to demonstrate the safety and effectiveness of the Guidant EASYTRAK 3 Downsize Lead in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Must be indicated for a Guidant CRT-P or CRT-D device
- •Creatinine < 2.5 mg/dL obtained no more than two weeks prior to enrollment
- •Age 18 or above, or of legal age to give informed consent specific to state and national law
- •Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigation center and at the intervals defined by this protocol
- •Geographically stable residents who are available for follow-up
排除标准
- •Have a known hypersensitivity to a 0.5 mg nominal dose of dexamethasone acetate
- •Have or had previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted LV lead placement
- •Have pre-existing cardioversion/defibrillation leads or right ventricular pacing leads other than those specified in the investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads)
- •Currently requiring dialysis
- •Have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment
- •Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
- •Documented life expectancy of less than six months or expected to undergo heart transplant within the next six months
- •Enrolled or participating in any concurrent study, including drug investigations, without Guidant written approval, that may confound the results of this study
- •Have a pre-existing unipolar pacemaker that will not be explanted/abandoned
- •Have a mechanical tricuspid heart valve
- •Women who are pregnant or plan to become pregnant. Note: Women of childbearing potential must have a negative pregnancy test within seven days of enrollment.
结局指标
主要结局
Lead-related complication-free rate at one-month
时间窗: 1 month
Chronic mean pacing thresholds at one-month.
时间窗: 1 month
次要结局
- Chronic mean R-wave amplitudes at one-month(1 month)
- Chronic mean pacing impedances at one-month.(1 month)
研究者
研究点 (2)
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