NCT00669357No Longer Available不适用
AbioCor Implantable Replacement Heart
适应症
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- Abiomed Inc.
研究概览
简要总结
Abiocor is a post market approval study for an Implantable Replacement Heart. This post approval study is currently on hold.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in severe biventricular end stage heart disease who are not cardiac transplant candidates and who are adults less than 75 years old, require multiple inotropic support, are not treatable by LVAD destination therapy, and are not weanable from biventricular support if on such support.
排除标准
- •Patients with other irreversible end organ dysfunctions that would compromise survival, having in clinical assessment a more than 30% chance of survival beyond 30 days, inadequate psychosocial support, or patients in whom fit is a problem, based on preoperative noninvasive anatomical assessment showing that the thoracic volume is unable to accommodate the device.
研究者
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