Clinical Protocol for Evaluation of the Jarvik 2000 Heart Assist System
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Survival to cardiac transplantation or survival and transplant listed at 180 days following implant of the Jarvik 2000 Heart.
研究概览
简要总结
The purpose of the study is to determine the safety and effectiveness of the Jarvik 2000 Heart as a bridge to heart transplantation in end-stage heart failure patients who are approved heart transplant candidates.
详细描述
The Jarvik 2000 Heart is a silent compact axial flow impeller pump of 1 inch diameter, weighing 90g with a displacement volume of 25ml. The pump is implanted into the apex of the left ventricle by left thoracotomy, or by mid-sternotomy, or by the subcostal approach. A vascular graft offloads to either the descending thoracic aorta, the ascending thoracic aorta, or the abdominal aorta. The impeller rotates at speeds of 8,000 to 12,000 rpm providing blood flow of up to seven L/minute. At higher speeds the pump can produce 10 L/minute. Power is provided through an abdominal drive line.
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
- •(The following are general inclusion criteria; more specific criteria are outlined in the study protocol).
- •Transplant listed UNOS status IA or IB patients.
- •BSA >1.5 m2 and <2.3 m
- •Dependent on one or more intravenous inotropic agents or an intraaortic balloon pump (IABP).
排除标准
- •(The following are general exclusion criteria; more specific criteria are outlined in the study protocol).
- •Known risk factors or conditions that would contraindicate LVAD implantation or adversely affect patient survival.
- •Evidence of end organ dysfunction.
- •Known coagulopathy or contraindication of anticoagulation or antiplatelet agents.
- •Systemic infection.
- •Malignancies not in remission.
- •Current participation in investigational trials with other devices, drugs, or biologic agents.
结局指标
主要结局
Survival to cardiac transplantation or survival and transplant listed at 180 days following implant of the Jarvik 2000 Heart.
时间窗: 180 days
次要结局
- Incidence of serious adverse events as events per patient month including infection, stroke, VAD failure, and all serious adverse events. Quality of Life measures - MLHFQ, NYHA class, Neurocognitive assessments.(180 days)