NCT00158938已完成2 期
Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 115
- 主要终点
- Pacing thresholds at 6 months
研究概览
简要总结
The purpose of this clinical investigation was to assess the safety and effectiveness of the EASYTRAK 3 lead
详细描述
This clinical study was a prospective, multi-center, clinical evaluation to document safety and effectiveness of the EASYTRAK 3 lead in humans. Patients implanted with the EASYTRAK 3 lead were followed through pre-discharge, 1-month, 3-month and 6-month follow-ups
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
- •Moderate to severe heart failure (NYHA Class III/IV) including left ventricular dysfunction (EF <= 35%) and QRS duration >= 120 ms remaining symptomatic despite stable, optimal heart failure drug therapy.
- •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 investigational center and at the intervals defined by this protocol.
排除标准
- •A known hypersensitivity to a 1.0 mg (0.5 mg per electrode) dose of dexamethasone acetate.
- •Previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted LV lead placement.
- •Pre-existing cardioversion/defibrillation leads other than those specified in this investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads).
- •Requiring dialysis.
- •A myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment.
- •Hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis).
- •A documented life expectancy of less than 6 months or expected to undergo heart transplant within 6 months.
- •Enrolled in any concurrent study, without prior Guidant written approval, that may confound the results of this study.
- •Have a mechanical tricuspid heart valve.
结局指标
主要结局
Pacing thresholds at 6 months
Pacing impedances at 6 months
R-wave amplitudes at 6 months
6-month complication free rate
次要结局
- left ventricular bipolar pacing and sensing with RENEWAL 3 H173 safety
研究者
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