Deactivation of Implantable Cardioverter Defibrillator During Non-thoracic Surgical Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Electromagnetic oversensing will be reported as a percentage of the total enrolled patients
研究概览
简要总结
The purpose of this study is:
- To document the incidence of electromagnetic oversensing of ICDs during non-thoracic surgery.
- To identify any non-thoracic procedure with a higher incidence of generating electromagnetic oversensing.
- To document the ability of dual chamber ICDs to discriminate electromagnetic oversensing.
详细描述
Electrocautery devices used during surgery generate a high electromagnetic field with a frequency that may result in ICD oversensing. Oversensing may in turn result in false detection of a ventricular arrhythmia and for the ICD to discharge. Because of this possibility, patients frequently have their ICDs inactivated prior to the procedure.
Although oversensing appears to be highly unlikely in clinical practice, vast resources are utilized in the process of deactivating and reactivating ICDs for surgeries. In addition, there are reports of deaths from failure to reactivate ICDs following elective surgery.
In this study we intend to document the incidence of oversensing, identify procedures with a higher likelihood of oversensing and evaluate the ability of dual chamber ICDs to discriminate electromagnetic oversensing.
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
- 否
入选标准
- •Patients with Medtronic or Boston Scientific single and dual chamber ICDs
排除标准
- •Non-thoracic ICD generator placement (abdominal)
结局指标
主要结局
Electromagnetic oversensing will be reported as a percentage of the total enrolled patients
时间窗: Assessed at time of procedure
次要结局
- Non-thoracic procedures with a higher incidence of generating electromagnetic oversensing(Assessed at time of procedure)
- Incidence of dual chamber ICDs discriminating electromagnetic oversensing.(At time of procedure)