Master Study of the SIELLO Pacemaker Leads
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Ventricular threshold of SIELLO T (passive fixation)
研究概览
简要总结
The objective of this study is to prove the safety and efficacy of the SIELLO pacemaker leads.
详细描述
The assessment of the safety of SIELLO pacemaker leads is based on the collection of complications which are related to the leads. The assessment of efficacy of the SIELLO pacemaker leads is based on the collection of standard electrical lead data during the implant and follow-up procedures. Subsequent to the implantation of the SIELLO leads,five follow-up visits have been scheduled: at pre-discharge and after 1, 3, 6 and 12 months.
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
- 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
研究组 & 干预措施
Siello pacemaker lead
Patients with Siello Pacemaker lead
干预措施: Pacemaker therapy (Device)
结局指标
主要结局
Ventricular threshold of SIELLO T (passive fixation)
时间窗: 3 month follow-up visits
Complication free rate of all SIELLO leads
时间窗: 3 month follow-up visits
Atrial threshold of SIELLO S (active fixation)
时间窗: 3 month follow-up visits
次要结局
未报告次要终点