NCT01000532已完成不适用
Pilot Study to Compare Steroid (SIELLO T/JT) Versus Non-Steroid Pacing Leads (BPPU T/JT)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
研究概览
简要总结
This investigation is designed to demonstrate the clinical efficacy and safety of the low-dose drug of the SIELLO leads in comparison to the non-steroid BPPU leads in a clinical investigation.
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
- •Meet the indications for pacemaker therapy
- •Understand the nature of the procedure
- •Give informed consent
- •Able to complete all testing required by the clinical protocol
- •Available for follow-up visits on a regular basis at the investigational site
排除标准
- •Meet none of the pacemaker indications
- •Meet one or more of the contraindications
- •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
研究者
研究点 (1)
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