Acute Intra-operative Testing of Subcutaneous Implantable Defibrillator Emulator and Parasternal Electrode, Acutely Implanted, for Comparison With Transvenous System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
研究概览
简要总结
The purpose is to further evaluate the operation, safety, and feasibility of a subcutaneous implantable defibrillator (S-ICD) system in patients who require an implantable cardioverter defibrillator (ICD)for treating ventricular tachyarrhythmias. The S-ICD electrode and pulse generator emulator will be briefly implanted and tested during the standard implantation procedure of an ICD, but then the S-ICD system will be removed entirely.
详细描述
The objectives of this study are to further evaluate the S-ICD system's ability to identify and terminate induced ventricular tachyarrhythmias in patients acutely with an S-ICD emulator and parasternal electrode during the implant procedure of a standard transvenous ICD.
The active emulator is not a powered medical device and all elements of the test system are removed following the testing.
This acute intra-operative protocol will test the ability of the electrode and emulator to appropriately convert the arrhythmia and allos an assessment of post shock pacing.
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 requiring ICD therapy according to National Centre for Clinical Excellence (NICE) criteria are eligible
- •And patients who require replacement of an existing transvenous ICD system are eligible
排除标准
- •Patients unable or unwilling to provide informed consent
- •Any conditions which precludes the subject's ability to comply with the study requirements, including completion of the study
- •Females who are pregnant or lactating and pre-menopausal women who are unwilling to use adequate birth control for the duration of the study
- •Participation in another investigational device trial at any time during the conduct of this study
- •Patients with a serious medical condition and life expectancy of less than one year
- •Patients with documented spontaneous and frequently recurring VT that is reliably terminated with anti-tachycardia pacing
- •Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant