NCT00328705已完成不适用
D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management
Medtronic Cardiac Rhythm and Heart Failure5 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2006年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 5
- 主要终点
- Ventricular fibrillation (VF) detection time
研究概览
简要总结
This is an acute, prospective, multi-center, non-randomized, investigational device exemption (IDE) clinical study.
详细描述
The purpose of this study is to confirm the performance of new sensing circuitry, and to confirm the performance of a Ventricular Capture Management feature in subjects with implantable cardioverter defibrillator (ICD) leads connected to an external pacemaker/defibrillator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients who are scheduled for implantation or replacement of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
- •Patients must have or receive Medtronic transvenous atrial and ventricular leads in association with the scheduled device implant or replacement.
排除标准
- •Patients who have 3rd degree heart block, as assessed by the investigator
- •Patients who have a mechanical tricuspid heart valve
- •Patients who have received an investigational new drug or device, or are currently enrolled in a clinical study for a new indication of an approved drug or device
结局指标
主要结局
Ventricular fibrillation (VF) detection time
Ventricular Capture Management accuracy
次要结局
未报告次要终点
研究者
研究点 (5)
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