NCT05100836已完成不适用
SURPASS Study - The Surgical Unloading Renal Protection And Sustainable Support Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abiomed Inc.
- 入组人数
- 1,017
- 试验地点
- 15
- 主要终点
- Survival Outcome
研究概览
简要总结
A multi-center, prospective & retrospective, observational single-arm study of the clinical outcomes up to one year collected from electronic health records of patients which have undergone standard of care implantation of Impella 5.5, regardless of clinical situation or indication. All patients will be enrolled via an IRB-approved Waiver of Informed Consent and HIPAA Authorization.
All patients who were supported retrospectively (prior to site IRB approval) with Impella 5.5 at the investigative site will be entered into the SURPASS registry and specified as the retrospective cohort.
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
- •Age ≥ 18 years
- •Subject has previously undergone an Impella 5.5 implant at a study site
排除标准
- •Patients not receiving Impella 5.5
结局指标
主要结局
Survival Outcome
时间窗: One year
The rate of patients who survived at Impella 5.5 explant, hospital discharge and follow-up up to 1 year
次要结局
未报告次要终点
研究者
研究点 (15)
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