LUKS-Leads Registry on Long-term Performance of ICD Leads
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- performance of lead impedance
研究概览
简要总结
All patients having an implantable cardiac defibrillator (ICD) implanted and having follow-up at the Cantonal Hospital Lucerne (LUKS), the investigator center, are included in this retrospective ICD lead registry from 2006 onwards. Data is collected prospectively from december 2016 onwards. After certain ICD-leads tended to fail early the investigators aimed for a registry monitoring our patient population with defibrillator leads and evaluating their long-term performance.
详细描述
All patients having an ICD implanted and having follow-up at the investigators center are included in this retrospective ICD lead registry from 2006 onwards. Data is collected prospectively from december 2016 onwards. After certain ICD-leads tended to fail early the investigators aimed for a registry monitoring our patient population with defibrillator leads and evaluating their long-term performance.
The following parameters will be measured during regular clinical controls: electronic impedances, threshold values, sensing values, battery performance, inadequate/adequate shock release und software problems
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients being implanted with a Defibrillator lead from 2006 onwards
排除标准
- •documented refusal of data collection for scientific purposes
结局指标
主要结局
performance of lead impedance
时间窗: regular clinical controls within 10 years
electronic impedances in Ω
performance of lead sensing
时间窗: during regular clinical controls within 10 years
sensing values in millivolt (mV)
performance of lead threshold
时间窗: during regular clinical controls within 10 years
threshold values in V
control system of defibrillator
时间窗: during regular clinical controls within 10 years
software problems in numbers and descriptive
lead parameters
时间窗: during regular clinical controls within 10 years
battery performance in %
performance of defibrillator
时间窗: during regular clinical controls within 10 years
inadequate/adequate shock release in numbers
次要结局
未报告次要终点
研究者
Richard Kobza
PD Dr. med.
Luzerner Kantonsspital
