跳至主要内容
临床试验/NCT00614718
NCT00614718已完成不适用

Failure of Chronically Implanted Defibrillator Leads -Incidence and Management A Retrospective Multicenter Study

University Hospital, Basel, Switzerland3 个研究点 分布在 2 个国家目标入组 1,317 人开始时间: 1993年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,317
试验地点
3
主要终点
Time to lead failure or lead failure recurrence

研究概览

简要总结

Comparison of two different approaches to address the problem of malfunctioning ICD-leads. These leads consist of two parts. One that is used for detection of arrhythmias(and pacing if required) (Pace/Sense) and a second part that is used to deliver therapy is needed (Shock-coil).

The two approaches compared are:

Replacement of the entire lead in case of any lead malfunction versus placement of an additional pace/sense-lead if the shock-coil of the exiting lead was still functional.

详细描述

Therapy with an implantable cardioverter defibrillator (ICD) has become a standard treatment for an increasing number of patients suffering from different types of heart diseases which can lead to fatal arrhythmias. This therapy was established about 20 Years ago and malfunctioning electrodes of these devices have been, and still are a serious problem leading to inappropriate therapy (shocks)or missed live saving therapy.

In case of a malfunctioning electrode it is established clinical practice to either replace the entire ICD electrode (which is used for detecting the arrhythmias as well as delivering the shock) or just to implant an additional electrode for detection of the arrhythmia (and pacing if required) given that the "shock"-part of the existing electrode is still functional.

There is no longterm outcome data comparing these two strategies. We included 1317 consecutive patients with an ICD implanted at three European centers between 1993 and 2004. Incidence of lead failure, type of lead used, approach and outcome were evaluated.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Implantation of an ICD between 1993 and 2004

排除标准

  • 未提供

结局指标

主要结局

Time to lead failure or lead failure recurrence

时间窗: from inclution to death or end of follow up (Jan 2004)

次要结局

未报告次要终点

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other

研究点 (3)

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