NCT01487941已完成不适用
Efficacy and Safety of the Setrox JS Lead (J=J-shaped, S=Screw)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Serious Adverse Device Effect rate
研究概览
简要总结
The purpose of this study is the evaluation of safety and efficacy of the pacemaker lead "Setrox JS".
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Meet the indications for pacemaker therapy
- •Available for follow-up visits on a regular basis at the investigational site
- •Contractual capability and ability to consent
- •Age ≥18 years
排除标准
- •Meet one or more of the contraindications for pacemaker therapy
- •Permanent atrial fibrillation
- •Have a life expectancy of less than six months
- •Cardiac surgery in the next six months
- •Enrolled in another cardiac clinical investigation
- •Have other medical devices that may interact with the implanted pacemaker
- •Pregnant and breast-feeding women
结局指标
主要结局
Serious Adverse Device Effect rate
时间窗: 6 months
Atrial pacing threshold from Setrox JS at 3 month follow-up < 1.0V
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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