NCT03831048已完成不适用
Clinical Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death (DCD Heart Trial)
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
- 180
- 试验地点
- 49
- 主要终点
- Survival
研究概览
简要总结
To evaluate the effectiveness 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.
详细描述
A prospective, randomized and concurrent controlled, non-inferiority pivotal trial in which subjects who receive a DCD donor heart transplant will be compared to subjects who receive a standard criteria donor heart transplant (Standard of Care 1 [SOC1] and Standard of Care 2 [SOC2] - from both randomized and concurrent control groups), adjusting for differences in risk factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Survival
时间窗: 6 months
Patient survival 6 months post-transplant
次要结局
- Utilization Rate(Within 24 hours post-transplant)
研究者
研究点 (49)
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