NCT01361672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
- 1,140
- 主要终点
- Model 4296 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 4296 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 4296 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 4296 LV Lead-related complication rate
时间窗: 5 years
To demonstrate that the Model 4296 lead-related complication-free probability
次要结局
- Types of lead-related adverse device effects(5 years)
- Percent of subjects with changes in electrode programming(5 years)
- Number of fractures with and without loss of function(5 years)
- Bipolar electrical performance at 1 year(1 year)
- Bipolar pacing impedance(1 year)
- Bipolar pacing capture threshold(1 year)
研究者
相似试验
已完成
不适用
Model 4396 Left Ventricular (LV) Lead Chronic Performance StudyHeart FailureNCT01361685Medtronic366
已完成
不适用
Attain Performa™ Left Ventricular (LV) Quadripolar Leads Chronic Performance StudyHeart FailureNCT02294331Medtronic1,900
已完成
不适用
Model 4196 Left Ventricular (LV) Lead Chronic Performance StudyHeart FailureNCT00930904Medtronic1,847
已完成
不适用
Attain Model 4196 Left Ventricular (LV) LeadHeart FailureNCT00271544Medtronic Cardiac Rhythm and Heart Failure190
招募中
不适用
Conservative Management of Left Ventricular Assist Device CandidatesAdvanced Heart FailureNCT05271214Tel-Aviv Sourasky Medical Center100