Performance of the New Generation of Sorin Group Brady Leads In a Normal Hospital Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LivaNova
- 入组人数
- 2,254
- 试验地点
- 1
- 主要终点
- Lead dislodgment rate in acute phase
研究概览
简要总结
This observational study is a non-interventional multi-centre, prospective study.
The aim of the study is to evaluate the Sorin Group new passive- and active- fixation pacing leads. We plan to assess the acute and short term lead dislodgment rate (within the first three months following implantation) correlated with the type of lead (active- or passive- fixation). Further, we are collecting data related to leads handling and leads electrical performances
详细描述
The primary objective of this observational study is to assess the acute rate of dislodgment of the new Sorin group range of active- and passive- fixation leads up to 3 months following implant.
Assessment of electrical performances (pacing threshold, sensing amplitude, impedance) of the leads at implant and during follow-up.
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
- •The implanted lead must allow the measurement of pacing threshold at 0.5ms, R-wave or P-wave amplitude and impedance of the lead.
- •Included patients may receive more than one lead under evaluation.
排除标准
- •Any contraindication to endocavitary lead implantation;
- •Inability to understand the purpose of the study or refusal to co-operate.
- •Geographically unstable or unavailability for scheduled M1-M3 follow-up at the implanting centre as defined in the investigational plan.
- •Patient of minor age (<18)
- •Pregnancy.
结局指标
主要结局
Lead dislodgment rate in acute phase
时间窗: Lead dislodgment
Ventricular active fixation leads = 1.57%; Ventricular passive fixation leads = 3.23%, Atrial active fixation leads = 1.04%
次要结局
未报告次要终点