NCT01361685已完成不适用
Attain Ability® Family Left Ventricular Lead Chronic Performance Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medtronic
- 入组人数
- 366
- 试验地点
- 50
- 主要终点
- Model 4396 LV Lead-related complication rate
研究概览
简要总结
Lead survivability will be summarized.
详细描述
The purpose of this study is to evaluate long-term performance of the 4396 LV Lead. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4396 LV Lead. This study is conducted within Medtronic's post-market surveillance platform.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Model 4396 LV Lead-related complication rate
时间窗: 5 years
次要结局
- Bipolar pacing impedance(1 year)
- Bipolar pacing capture threshold(1 year)
- Number of fractures with and without loss of function(5 years)
- Types of lead-related adverse device effects(5 years)
- Bipolar electrical performance at 1 year(1 year)
- Percent of subjects with changes in electrode programming(5 years)
研究者
研究点 (50)
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