NCT00940888已完成不适用
SJ4 Post Approval Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,701
- 试验地点
- 1
- 主要终点
- Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector
研究概览
简要总结
The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Have an approved indication per ACC/AHA/HRS guidelines for implantation of heart failure or life-threatening ventricular tachyarrhythmias and will be implanted with a St. Jude Medical SJ4 system.
- •Have the ability to provide informed consent for study participating and be willing and able to comply with the prescribed follow-up test and schedule of evaluations.
排除标准
- •Be currently participating in a clinical investigation that includes an active treatment arm.
- •Have a life expectancy of less than 6 months due to any condition.
- •Be less than 18 years of age.
结局指标
主要结局
Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector
时间窗: 5 years
Right Ventricle (RV) Bipolar Capture Thresholds
时间窗: 5 years
次要结局
未报告次要终点
研究者
研究点 (1)
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