NCT01090401已完成4 期
PME/Master Study of the Linoxsmart S DX ICD Leads
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Rate of atrial adequate sensing
研究概览
简要总结
The objective of this study is to prove the safety and efficacy of the Linox smart S DX ICD lead.
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 with standard ICD indication
- •Be available for follow-up visits on a regular basis at an approved investigational center
排除标准
- •Patients with standard ICD contra-indication
- •Patients with permanent atrial fibrillation
- •Have a life expectancy of less than six months
- •Are expecting to receive cardiac surgery within 6 months after enrollment
- •Age < 18 years
- •Not enrolled in another cardiac clinical investigation
结局指标
主要结局
Rate of atrial adequate sensing
时间窗: 6 months
次要结局
- Linox smart S DX related complication-free rate(6 months)
研究者
研究点 (2)
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