NCT01777607Unknown不适用
The Use of Impella RP Support System in Patients With Right Heart Failure: A Clinical and Probable Benefit Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- Abiomed Inc.
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Primary Benefit Endpoint
研究概览
简要总结
The use of Impella RP is safe, feasible and provides a hemodynamic benefit in patients with right ventricular failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients that have developed signs of right ventricular failure either: A) within 48 hours post-implantation of an FDA approved implantable surgical LVAD (left ventricular assist device )(Cohort A) or B) subsequent to postcardiotomy shock within 48 hours post surgery or post myocardial infarction (Cohort B).
- •Age ≥18 years old
- •Signed Informed consent
- •Exclusion Criteria
- •INTERMACS 1 patients (Critical cardiogenic shock patient who is "crashing and burning", has life-threatening hypotension and rapidly escalating inotropic or pressor support, with critical organ hypoperfusion often confirmed by worsening acidosis and lactate levels)
- •Evidence of acute neurologic injury
- •RA(right atrium),RV (right Ventricle) and/or PA (pulmonary artery) thrombus
- •Intolerance to anticoagulant or antiplatelet therapies
- •Existing congenital heart disease that would preclude the insertion of the device.
- •Participation in any other clinical investigation that is likely to confound study results or affect study outcome
- •Acute Myocardial Infarction (AMI) with mechanical complications ( ventricular septal defect, myocardial rupture, papillary muscle rupture)
排除标准
- 未提供
研究组 & 干预措施
Intervention
Experimental
干预措施: IMPELLA® RP (Device)
结局指标
主要结局
Primary Benefit Endpoint
时间窗: 30 Days
Survival at 30 days or hospital discharge whichever is longer post device explant or to the next therapy, including transplant, bridge to transplant or destination therapy with FDA approved surgical VAD (Ventricular Assit Device).
次要结局
未报告次要终点
研究者
研究点 (4)
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