NCT00955708终止不适用
Condition of Approval Study: Longitudinal Surveillance Registry of the ACUITY Spiral Lead
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,308
- 试验地点
- 96
- 主要终点
- Chronic Left Ventricular Lead-related Complication Free Rate
研究概览
简要总结
The primary purpose of the LSR of ACUITY Spiral is to evaluate and report on the long-term performance of the ACUITY Spiral Left Ventricular Lead.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has been or will be implanted with the ACUITY Spiral Lead within 29 days
- •Plans to remain in the long-term care of his/her enrolling physician
- •Is willing and capable (or appropriate legal representative) of authorizing access to and use of health information as required by an institution's institutional review board (IRB)
- •Is willing and capable (or appropriate legal representative) of providing authorization for participation in the registry
排除标准
- •Is unable or unwilling to comply with the protocol requirements
结局指标
主要结局
Chronic Left Ventricular Lead-related Complication Free Rate
时间窗: Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death).
次要结局
未报告次要终点
研究者
研究点 (96)
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