NCT04615182已完成不适用
The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- TransMedics
- 入组人数
- 90
- 试验地点
- 49
- 主要终点
- Patient Survival
研究概览
简要总结
The Portable Organ Care System (OCS™) Heart for Resuscitating, Preserving and Assessing Hearts Donated after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
详细描述
To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
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
- •• Primary heart transplant candidates
- •Age ≥ 18 years old
- •Signed: (1) written informed consent document; (2) authorization to use and disclose protected health information; and (3) consent to TransMedics' use of recipients' UNOS/OPTN data and recipients' INTERMACS data.
排除标准
- •Prior solid organ or bone marrow transplant
- •Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
- •Multi-organ transplant.
结局指标
主要结局
Patient Survival
时间窗: 6 months post-transplant
Patient survival at 6 months post-transplant.
次要结局
- Utilization Rate(24 hours post transplant)
研究者
研究点 (49)
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