跳至主要内容
临床试验/NCT03521050
NCT03521050招募中不适用

LUKS-Leads Registry on Long-term Performance of ICD Leads

Luzerner Kantonsspital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2016年12月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Kobza

PD Dr. med.

Luzerner Kantonsspital

研究点 (1)

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