NCT00146822已完成4 期
ENDOTAK RELIANCE G Evaluation of Handling and Electrical Performance Study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,500
- 主要终点
- Lead electrical properties
研究概览
简要总结
The REFLEx Study will evaluate if ENDOTAK RELIANCE G defibrillation leads with GORE ePTFE-covered coils are as good as or better than other comparative commercially available defibrillation leads with respect to electrical performance and termination efficacy in spontaneous tachyarrhythmic episodes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single
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 current ICD or CRT-D indications
- •Patients who are going to be implanted with one of the aforementioned ICD or CRT-D devices
- •Patients who are going to be implanted with active-fixation, dual-coil, endocardial defibrillation leads with compatible connectors (i.e., ENDOTAK RELIANCE G or study-comparative ICD leads)
- •Patients who sign and date a Patient Informed Consent form prior to device implant
- •Patients who remain in the clinical care of the enrolling physician in approved centers
- •Patients who are at least 18 years old
排除标准
- •Patients who have a preexisting transvenous lead system that is not completely explanted
- •Patients who are hypersensitive to a single dose of approximately 1.0 mg of dexamethasone acetate
- •Patients who are expected to receive a heart transplant during the duration of the study
- •Patients whose estimated life expectancy is less than 12 months due to other medical conditions
- •Patients who currently have or who are likely to receive a tricuspid valve prosthesis
- •Patients who are likely to have an open-chest surgery in the next three months
- •Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the REFLEx study.
- •Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study
- •Patients who are pregnant
结局指标
主要结局
Lead electrical properties
First shock conversion success rate for spontaneous fast ventricular tachycardia or ventricular fibrillation
次要结局
- Lead handling characteristics
- Effects of ischemia and revascularization and previous lead extraction on the lead's electrical performance
- Lead migration/dislodgment rates
- Characterize the current ICD/CRT-D population
研究者
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