NCT02497950已完成不适用
Evaluating the HeartMate 3™ in a Post-Market Approval Setting: The HeartMate 3 Registry (ELEVATE™)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 540
- 试验地点
- 26
- 主要终点
- Survival
研究概览
简要总结
Evaluate real-world experience of HeartMate 3 (HM3) in post-approval setting.
详细描述
The purpose of this post-market registry is to collect data and evaluate the real-world experience of the HeartMate 3 Left Ventricular Assist System (HM3 LVAS) in a post-approval setting.
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
Survival
时间窗: Up to 5 Years post-implant
Patients will be followed in the registry to 5 years post-implant or outcome (transplanted, explanted for recovery or expired), whichever occurs first.
次要结局
- EuroQoL-5D-5L (EQ-5D-5L) VAS(Baseline, 1, 2, 3, 4, 5 years while the patient is being supported on the HM3 LVAS)
- Six Minute Walk Test (6MWT)(At 5 years after implant)
- New York Heart Association (NYHA) Classification(At 5 years after implant)
- Adverse Events(Up to 5 years post-implant)
- Device Malfunctions(Up to 5 years post-implant)
- Reoperations(Up to 5 years post-implant)
- Rehospitalizations(Up to 5 years post-implant)
研究者
研究点 (26)
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