The WiSE®-UP Study (The WiSE System Utilization & Performance Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 12
- 主要终点
- Primary Safety
研究概览
简要总结
Observe to understand product performance, including patient safety, clinical outcomes, and CRT response information associated with the use of the market-released WiSE System
详细描述
The WiSE-UP Study is a prospective, real-world, observational study aimed at understanding acute and long-term product performance, including patient safety, clinical outcomes, and CRT response information associated with the use of the market-released WiSE System.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient or legally authorized representative can provide written authorization and/or consent per institution requirements.
- •Patient is intended to receive a WiSE System and passed the acoustic window screening
- •Patient who is, or will be, accessible for follow-up.
- •Participation is not excluded by local law.
- •Patient is not enrolled in a concurrent drug and/or device study that may confound the Registry results.
- •Patient life expectancy >1 year.
排除标准
- 未提供
研究组 & 干预措施
Single-arm, prospective, multicenter, observational study.
Market-released WiSE System approved for commercial release with a market-released co-implanted system are eligible.
干预措施: The Wise System (Device)
结局指标
主要结局
Primary Safety
时间窗: 1, 6, 12, 24, 48 and 60 months
The primary outcome measure of the Study is the rate of serious adverse events (SAEs) at \< 30 days post implant related to the WiSE System and/or implant procedure.
次要结局
- Efficacy 3(6 months)
- Efficacy 1(1 month)
- Efficacy 2(1 month)
- Efficacy 4(6 months)
- Efficacy 5(1, 6, 12, 24, 48 and 60 months)
- Efficacy 6(1, 6, 12, 24, 48 and 60 months)
- Efficacy 7(1, 6, 12, 24, 48 and 60 months)
- Efficacy 8(6 and 12 months)
- Efficacy 9(1, 6, 12, 24, 48 and 60 months)
- Efficacy 10(1, 6, 12, 24, 48 and 60 months)
- Efficacy 11(1, 6, 12, 24, 48 and 60 months)
- Efficacy 10(1, 6, 12, 24, 48 and 60 months)
- Efficacy 11(1, 6, 12, 24, 48 and 60 months)
- Efficacy 1(1 month)
- Efficacy 2(1 month)
- Efficacy 3(6 months)
- Efficacy 4(6 months)
- Efficacy 5(1, 6, 12, 24, 48 and 60 months)
- Efficacy 6(1, 6, 12, 24, 48 and 60 months)
- Efficacy 7(1, 6, 12, 24, 48 and 60 months)
- Efficacy 8(6 and 12 months)
- Efficacy 9(1, 6, 12, 24, 48 and 60 months)