NCT03022461已完成不适用
HeartMate 3 CE Mark Study Long Term Follow-up Clinical Investigation Plan
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 8
- 主要终点
- Survival
研究概览
简要总结
The purpose of this clinical investigation is to report the long term survival and incidence of adverse events in the patients who were implanted with HM3 in the CE Mark Study and continue to be ongoing with the HeartMate 3 LVAS after the CE Mark Study 2 year follow-up.
The study will be a single arm, prospective, multi-center, non-blinded and non-randomized study, intended to report on the long term use of the HeartMate 3 LVAS in those patients that completed the 2-year follow-up in the HeartMate 3 CE Mark study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patient or legal representative has signed Informed Consent Form (ICF).
- •Patient was enrolled in the HeartMate 3 CE Mark Study and continues to be supported with the HeartMate 3 LVAS after the 2 year CE Mark study follow-up.
排除标准
- •Patient does not consent to the continued data collection.
结局指标
主要结局
Survival
时间窗: At 5 years post HM3 CE Mark study implant
Subject outcomes and survival over time
次要结局
- Adverse Events(Between 2 and 5 years post HM3 CE Mark study implant)
- Percentage of Participants Who Survived Without Experiencing a Debilitating Stroke (MRS>3)(As it may occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first)
- Device Malfunctions(Between 2 and 5 years post HM3 CE Mark study implant)
- EuroQoL 5D-5L (EQ-5D-5L) VAS Score(At 5 years post HM3 CE Mark study implant)
- New York Heart Association (NYHA)(At 5 years post HM3 CE Mark study implant)
- Rehospitalizations(Between 2 and 5 years post HM3 CE Mark study implant)
- Six Minute Walk Test (6MWT)(At 5 years post HM3 CE Mark study implant)
- Reoperations(Between 2 and 5 years post HM3 CE Mark study implant)
研究者
研究点 (8)
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