US National OCS Heart Perfusion (OHP) Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- TransMedics
- 入组人数
- 100,000
- 试验地点
- 37
- 主要终点
- Recipients' patient and graft survival
研究概览
简要总结
This Registry is a sponsor initiated, multi-center, observational post-approval registry with independent academic oversight.
详细描述
The objective of this US National OHP Registry is to collect data on the post-transplant clinical outcomes of all donor hearts preserved and assessed on the OCS Heart System and to document the performance of the OCS Heart device in the real-world setting after FDA approval in the US.
The US National OHP Registry will enroll all heart transplant recipients who are transplanted with an OCS-perfused donor heart in the Registry. Patients' clinical outcomes will be followed up to five years post-transplant, loss to follow up, or death, whichever occurs first.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 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
Recipients' patient and graft survival
时间窗: Up to 5 years post-transplant
Recipients' patient and graft survival rates will be the primary clinical outcomes measures for all OCS Heart transplanted recipients compared to recipients receiving heart transplants using non-OCS preservation methods (cold static storage or other perfusion devices or a combination of both). This data will be obtained directly from UNOS/OPTN database.
次要结局
未报告次要终点