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临床试验/NCT01829269
NCT01829269已完成不适用

French Attitude Registry in Case of ICD Lead Replacement

French Cardiology Society1 个研究点 分布在 1 个国家目标入组 559 人开始时间: 2013年4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
559
试验地点
1
主要终点
Explanted probes

研究概览

简要总结

The average survival rate of a defibrillation lead is 91 to 99% at 2 years, 85-95% at 5 years and 60-72% at 8 years. We must also manage alerts for defibrillation probes with a higher complication rate than average. We will therefore be increasingly confronted with faulty sensors or at risk to be replaced.

There are no standardized approach for replacing defibrillation lead. A record made in the United States showed significant differences according to the teams strategy in case of failure of defibrillation lead in particular with regard to the decision to explant or abandon the probe.

The risk of extracting a defibrillation lead are well known with a major complication rate of 1.6 to 1.95%.

Regarding the risk of complications related to the abandonment of a probe we have less data. For some there is no risk to abandon a defibrillation lead. But others reported a complication rate of 5.5% related to pacing discontinued.

Main objective: Collect the attitude of different centers and different operators when replacing a failed defibrillation lead or "at risk." Explantation or abandonment of the sensor replaced.

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

入选标准

  • Patient to receive a replacement defibrillation lead not motivated by an infection and having been informed.
  • Patient who agreed to participate in the study
  • Patients aged 18 years and over
  • No Exclusion Criteria

排除标准

  • 未提供

结局指标

主要结局

Explanted probes

时间窗: 2 years

Percentage of explanted probes among implanted ones

次要结局

  • Complications of explantation(2 years)

研究者

发起方
French Cardiology Society
申办方类型
Other
责任方
Sponsor

研究点 (1)

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