NCT01626768已完成不适用
Medtronic Market-Released DF4 Lead Imaging
Medtronic Cardiac Rhythm and Heart Failure0 个研究点目标入组 37 人开始时间: 2012年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 主要终点
- In vivo lead shape
研究概览
简要总结
The Medtronic Market-Released DF4 Lead Imaging Study is a prospective, non-randomized study, multi-center clinical investigation.
The purpose of this clinical investigation is to collect high quality medical images of the Medtronic Market-Released DF4 lead in the shoulder and heart. Images collected during the study will allow for lead design and testing processes better tailored to the implanted environment.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients greater than 18 years of age.
- •Patients able and willing to attend imaging session.
- •Patients able and willing to give informed consent.
- •Patients with an implanted device/lead(s) for a minimum of 3 months.
排除标准
- •Subjects who require a legally authorized representative to obtain consent.
- •Subjects with exclusion criteria required by local law (e.g. age, breastfeeding
- •Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control.
结局指标
主要结局
In vivo lead shape
时间窗: Six Months
次要结局
未报告次要终点
研究者
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