NCT05047068进行中（未招募）不适用
OCS Heart Perfusion (OHP) Post-Approval Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- TransMedics
- 入组人数
- 350
- 试验地点
- 27
- 主要终点
- Patient Survival
研究概览
简要总结
The objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve DBD and DCD donor hearts.
详细描述
Multi-center, observational post-approval registry to:
- compare patient and graft survival of adult primary heart transplant recipients receiving DBD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period, and
- compare patient and graft survival of adult primary heart transplant recipients receiving DCD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Adult primary heart transplant recipients of DBD or DCD donor hearts perfused on the OCS Heart System.
排除标准
- •Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
- •On renal dialysis at time of transplant.
- •Donor Exclusion Criteria (for DCD Donor Hearts only):
- •Warm ischemic time > 30 minutes (warm ischemic time is defined as: Time from when mean systolic blood pressure (SBP) is < 50 mmHg or peripheral saturation < 70% to aortic cross-clamp and administration of cold cardioplegia in the donor).
结局指标
主要结局
Patient Survival
时间窗: One year post-heart transplant
Patient survival at one-year post-heart transplant.
次要结局
未报告次要终点
研究者
研究点 (27)
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