NCT02323321已完成不适用
International Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation (EXPAND Heart Trial)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- TransMedics
- 入组人数
- 75
- 试验地点
- 11
- 主要终点
- Patient Survival at Day-30 Post Transplant and Absence of Severe Primary Heart Graft Dysfunction in the First 24 Hours Post-transplantation
研究概览
简要总结
To evaluate the effectiveness of the OCS™ Heart to recruit, preserve and assess donor hearts that may not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization 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
- •Registered male or female primary Heart transplant candidate
- •Age ≥18 years old
排除标准
- •Prior solid organ or bone marrow transplant
- •Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
- •Multi-organ transplant
研究组 & 干预措施
OCS Preservation
Experimental
OCS Preservation and Assessment
干预措施: Preservation of Hearts for Transplantation (Device)
结局指标
主要结局
Patient Survival at Day-30 Post Transplant and Absence of Severe Primary Heart Graft Dysfunction in the First 24 Hours Post-transplantation
时间窗: 30 Days
A composite endpoint of patient survival at Day-30 post-transplant and absence of severe heart primary graft dysfunction (PGD) (left or right ventricle)) in the first 24 hours post-transplantation.
次要结局
未报告次要终点
研究者
研究点 (11)
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