NCT01117792已完成不适用
Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 8
- 主要终点
- Conversion of Induced Ventricular Fibrillation
研究概览
简要总结
The primary objective is to evaluate the S-ICD system's ability to identify and terminate induced ventricular fibrillation in patients during the implant procedure. The safety and performance of the S-ICD system will also be assessed throughout the patient follow-up period.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Replacement of an existing implanted transvenous ICD system
- •Class I, Class IIa, or Class IIb ACC/AHA/HRS indications for patients without an existing transvenous ICD system
- •Age is >= 18 years
- •Appropriate pre-operative ECG as measured with a specially developed template
排除标准
- •Subjects unable or unwilling to provide informed consent
- •Any condition which precludes the subject's ability to comply with the study requirements
- •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 the S-ICD system trial without written consent from the sponsor.
- •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
- •Patients with impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with a GFR <= 29.
研究组 & 干预措施
S-ICD System
Experimental
干预措施: subcutaneous implantable defibrillator (S-ICD) system (Device)
结局指标
主要结局
Conversion of Induced Ventricular Fibrillation
时间窗: Testing done during the implant procedure
The total number of subjects the S-ICD System was successful at converting induced sustained ventricular fibrillation.
次要结局
未报告次要终点
研究者
研究点 (8)
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