NCT01771172已完成不适用
Acute Subcutaneous Defibrillation
Medtronic Cardiac Rhythm and Heart Failure8 个研究点 分布在 5 个国家目标入组 50 人开始时间: 2013年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System.
研究概览
简要总结
To assess the defibrillation efficacy of a subcutaneous defibrillation system.
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 must be undergoing implant of a commercially approved ICD system
- •Subject must be willing to provide Informed Consent
- •Subject must be > 18 years old
排除标准
- •Subject with impaired kidney function as measured by a glomerular filtration rate (eGFR) estimate < 29 mls/min/1.73m2 (recorded in the last six months)
- •Subject has high risk of infection
- •Subject has EF < 15%
- •Subject at high risk of stroke
- •having a device replacement
- •Subject with an implanted active non-ICD device, cardiac or non-cardiac (e.g., Neuro stimulator, Pacemaker)
- •Subject is indicated for CRT
- •Subject is pacemaker dependent
- •Subject enrolled in a concurrent study that may confound the results of this study
- •Subject has medical conditions that would limit study participation
- •Subject is pregnant
- •Subject meets exclusion criteria required by local law (e.g. age, breast feeding, etc.)
结局指标
主要结局
Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System.
时间窗: within the first day
次要结局
未报告次要终点
研究者
研究点 (8)
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