NCT00606710已完成不适用
Cognis and Teligen 100 HE and Reliance Quadripolar Defibrillation Lead (4-Site) Field Following
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 4
- 主要终点
- Appropriate detection of ventricular arrhythmias
研究概览
简要总结
The COGENT-4 Field Following Study will evaluate the clinical performance of the Boston Scientific TELIGEN 100 HE Implantable Cardioverter Defibrillator (ICD), the COGNIS 100 HE Cardiac Resynchronization Therapy ICD (CRT-D) systems and the RELIANCE 4-SITE defibrillation lead (when available). An optional sub-study will also evaluate the clinical performance of the Reverse Mode Switch (RMS) feature in the TELIGEN 100 HE DR ICD.
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
- •ICD indication according to normal clinical practice (for those patients receiving a TELIGEN 100 HE)
- •CRT-D indication according to normal clinical practice (for those patients receiving a COGNIS 100 HE)
- •Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational centre and at the intervals defined by this protocol
- •Geographically stable patients who are available for follow-up at a study centre
- •Age 18 or above, or of legal age to give informed consent specific to national law
排除标准
- •Documented life expectancy of less than six months or expected to undergo heart transplant within the next six months
- •Patients currently requiring dialysis
- •Women who are pregnant or plan to become pregnant. Method of assessment per physician discretion
- •Enrolled in any concurrent study
- •Patients implanted with the following leads which will not be abandoned:
- •Atrial or right ventricular unipolar leads
- •Patch defibrillation leads
- •Non-compatible defibrillation leads (e.g. 5/6mm)
结局指标
主要结局
Appropriate detection of ventricular arrhythmias
时间窗: Predischarge
次要结局
- Appropriate shock conversion(Predischarge)
研究者
研究点 (4)
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