Evaluation of the Impact of Bioimpedance Analysis in Patients With Cardiac Implantable Electronic Devices
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Assessing a change in CIEDs function while and after bioimpedance analysis
研究概览
简要总结
There are an increase number of patients with cardiac implantable electronic devices (CIEDs) such as pacemakers (PM) and implantable cardioverter-defibrillators (ICDs) worldwide. The current medical practice guidelines warn on performing bioimpedance analysis (BIA) in this group of patients to avoid any electromagnetic interference. These recommendations restrict the use of BIA in many patients with heart failure in whom BIA might be of great interest in detecting peripheral congestion and in guidance of treatment. However, it is not well known whether BIA can affect the function of cardiac devices. Investigators aimed to test the incidence of electromagnetic interference between BIA and CIEDs.
详细描述
Patients enrollment were during routine face-to-face consultations, scheduled for PM and ICDs interrogations. Investigators recorded before and after each BIA measure, the battery voltage of the device, lead impedance and stimulation thresholds. The device electrograms were monitored during BIA measurements to detect any electromagnetic interference or oversensing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
open
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient having a cardiac device with or without cardiac resynchronization
- •18 years of age and above
- •Patients with no pacing-dependent status
- •Patients who read, understood and signed written informed consent letter
排除标准
- •Patients with acute heart failure
- •Patients implanted in less than 2 months
- •Dysfunction of the device in a follow-up visit or in the inclusion visit
- •Patients with a particular device lead model prone to develop electronical problems such as Sprint Fidelis of Medtronic (Minneapolis, USA) or Riata of St. Jude Medical (St. Paul, USA)
- •Pregnancy
研究组 & 干预措施
Patients with cardiac implantable electronic devices
干预措施: Bioimpedance analysis (Drug)
结局指标
主要结局
Assessing a change in CIEDs function while and after bioimpedance analysis
时间窗: at 6 months
次要结局
- Lead noise loss, over or under sensing of CIEDs(At 6 months)