RECOVER I: IMPELLA® RECOVER® LP/LD 5.0 Support System: A Clinical Safety & Feasibility Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Abiomed Inc.
- 入组人数
- 17
- 试验地点
- 14
- 主要终点
- Frequency of Major Adverse Events
研究概览
简要总结
To demonstrate that that the device is safe and potentially efficacious for use as a left ventricular cardiac assist device for postcardiotomy patients who require hemodynamic support post weaning from cardiopulmonary bypass.
详细描述
To demonstrate that the device is safe and potentially efficacious for use as a left ventricular cardiac assist device for postcardiotomy patients who require hemodynamic support post weaning from cardiopulmonary bypass. Postcardiotomy patients, weaned from a cardiopulmonary bypass system (CPB) in need for hemodynamic support due to ineffective standard medical therapy will be considered for enrollment. An attempt shall be made to reverse the hemodynamic situation with medications (e.g. inotropes, vasopressors). The IMPELLA RECOVER LP/LD 5.0 will be implanted by the surgeon when no improvement in hemodynamics is observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving stable infusion of one high dose inotrope or two medium dose inotropes for a respective minimum time indicated.
- •Elevated Filling Pressures, PCWP or PA
- •Time to enrollment within 48 hours from weaning
排除标准
- •Renal dysfunction
- •Hepatic dysfunction
- •Right Ventricular failure defined.
- •LV or RV Thrombus
- •Other exclusions per protocol
结局指标
主要结局
Frequency of Major Adverse Events
时间窗: 30 day or discharge
次要结局
- Other Adverse Events Doppler echocardiography assessment of aortic valve function will be performed at explant and 30days and 3 month follow-ups.(3 months)