NCT00853645已完成不适用
Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Number of Participants With a Successful Induced Ventricular Fibrillation Conversion
研究概览
简要总结
Primary objective is to evaluate the safety and performance of the implanted Subcutaneous implantable cardioverter defibrillator (S-ICD) system. A maximum of 10 subjects were to be enrolled and followed for one month to collect data on the safety, efficacy, and performance of the implanted S-ICD system. Additionally, patient comfort will be assessed as will cosmetic outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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 transvenous implantable cardioverter defibrillator (ICD) system
- •American College of Cardiology/American Heart Association/Heart Rhythm Society (ACC/AHA/HRS) Class I or II indications for ICD implantation
- •Age >= 18 years
- •Appropriate pre-operative Electrocardiogram (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 ventricular tachyarrhythmias (VT) that is reliably terminated with anti-tachycardia pacing
- •Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant
- •Patients with chronic renal failure, i.e. with a creatinine level of >2.5 mg/dl unless prescribed drug therapy known to increase creatinine levels in which case the value should be <= 3mg/dl
结局指标
主要结局
Number of Participants With a Successful Induced Ventricular Fibrillation Conversion
时间窗: 30 days
Sustained ventricular fibrillation induced by the investigator is successfully converted. A successful conversion was defined as two consecutive successful shocks out of four attempts with either standard polarity or with reverse polarity.
次要结局
未报告次要终点
研究者
研究点 (4)
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