NCT02314598终止不适用
Therapy Coil Electrogram Collection Study
Medtronic BRC2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2015年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Number of Patients With Abnormal Electrograms During a Lead Issue
研究概览
简要总结
This is a prospective, non-randomized, multicenter, post market release study which will collect electrograms (EGMs) from patients at risk of a suspected insulation failure to the high voltage portion of the defibrillator lead and will evaluate the electrogram signals.
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
- •Subject is willing to sign and date the study Informed Consent form
- •Subject is at least 18 years of age (or older, if required by local law)
- •Subject is willing and able to wear a Holter monitor for up to 24 hours
- •Subject has been implanted with a Medtronic ICD or CRT-D device
- •Subject has an increased risk of lead insulation breach
排除标准
- •Subject has medical conditions that would limit study participation
- •Subject is enrolled in one or more concurrent studies that would confound the results of this study
结局指标
主要结局
Number of Patients With Abnormal Electrograms During a Lead Issue
时间窗: 24 hours
Number of patients with at least one instance of abnormal noise during recording. Electrograms will be collected during 24 hours and afterwards abnormalities in the electrograms will be visually identified.
次要结局
- Proportion of Patients With Abnormal Electrograms and Lead Failure(1 month)
- Additional Abnormal Electrogram Characteristics(1 month)
研究者
研究点 (2)
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