All-comers Registry Monitoring the Safety and Effectiveness of the Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.
试验速览
- 阶段
- 不适用
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Stroke rate
研究概览
简要总结
The purpose of this post market surveillance is to continue monitoring the safety and effectiveness of the Berlin Heart EXCOR® Pediatric. This surveillance includes an "all-comers" prospective cohort of pediatric (<22 years of age) patients implanted according to the IFU with the EXCOR® Pediatric.
详细描述
The Advanced Cardiac Therapies Improving Outcomes Network (Action) database will be used for the surveillance. The network was developed to determine best practice and improve quality in the pediatric mechanical circulatory support field. The registry Protocol and Manual of Operations will be followed by participating pediatric transplant hospitals. Quality assurance of the data will be monitored by the registry's data coordinating center.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Transplant eligible
- •Implanted with EXCOR Pediatric per IFU
排除标准
- •Having any contradictions for user per IFU
结局指标
主要结局
Stroke rate
时间窗: Until discontinuation of device support or 180 days
The primary endpoint is to demonstrate that the rate of stroke (ischemic or hemorrhagic) will be no worse than the pre-specified performance goal. The rate will be calculated as the proportion of subjects experiencing a stroke while on EXCOR® Pediatric support within the first 180 days post-implant. The upper bound of the 95% confidence interval for the observed stroke rate will be compared to the pre-specified performance goal of 30%.
次要结局
- Device effectiveness(Until discontinuation of device support or 180 days)
- Adverse Events(Until discontinuation of device support or 180 days)