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临床试验/NCT01665131
NCT01665131Unknown不适用

The Use of Subcutaneous Implantable Cardiac Defibrillators (ICDs) Following Extraction of Conventional ICDs

Guy's and St Thomas' NHS Foundation Trust0 个研究点目标入组 50 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
Length of hospital stay

研究概览

简要总结

Implantable cardiac defibrillators (ICDs) are devices that are put into patients at high risk of sudden cardiac death. They are used to treat life threatening heart rhythm disorders. They have conventionally consisted of a generator sitting under the skin of the chest and leads which pass from veins in the collar bone region to the heart. Problems with these devices can necessitate extraction, with the commonest reason being infection. If extraction is required for infection then re-implantation is usually deferred for approximately one week whilst antibiotics are given so that the risk of infection of the new device can be minimised. This has considerable implications for healthcare resources. A new ICD has been developed that is entirely subcutaneous with no intravenous element. It is already in clinical use and is positioned remote from conventional ICD sites. With no intravenous element there is very little risk of infection in the blood affecting the new device. It is therefore likely to be possible to re-implant these devices immediately after extracting a conventional system. The aim of this research is to assess the outcome in patients re-implanted with this device immediately after conventional ICD system extraction. This data will be compared compared to those who have conventional systems re-implanted after the necessary delay.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients fulfilling conventional criteria for ICD extraction and who require implantation of a further ICD without a need for pacing.

排除标准

  • Indication for anti-bradycardia pacing or cardiac resynchronisation therapy
  • Life expectancy < 1 year
  • Need for intravenous inotropes
  • Pregnancy

结局指标

主要结局

Length of hospital stay

次要结局

  • Rate of ICD infection(1 year)

研究者

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

Manav Sohal

Clinical Research Fellow

Guy's and St Thomas' NHS Foundation Trust

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