Berlin Heart EXCOR Pediatric Post Approval Study
试验速览
- 阶段
- 不适用
- 入组人数
- 49
- 主要终点
- Safety
研究概览
简要总结
The purpose of this post-approval study of the EXCOR® Pediatric VAD is to evaluate whether safety and outcomes of the device use in the commercial setting are comparable to the safety and outcomes of the device use in the IDE study.
详细描述
EXCOR® Pediatric is intended to provide mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients. Pediatric candidates with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support may be treated using the EXCOR® Pediatric.
Study Purpose The purpose of this post-approval study of the EXCOR® Pediatric VAD is to evaluate whether safety and outcomes of the device use in the commercial setting are comparable to the safety and outcomes of the device use in the IDE study. Because the device had extensive use (available to all North American sites who requested the device under compassionate use regulations), it is expected that the pre-approval and post-approval use will be similar.
The primary safety objective of the EXCOR® Pediatric VAD Post-Approval Study is to demonstrate that the serious adverse event (SAE) rate in subjects implanted with the EXCOR® Pediatric in the study is not greater than the rate experienced in the IDE study.
The primary effectiveness objective for the EXCOR® Pediatric VAD Post Approval Study is to assess the outcome following implantation of the EXCOR® Pediatric for transplant eligible children in need of mechanical circulatory support. Outcome is defined as transplant, recovery of left ventricular function or death.
The following secondary objectives will be summarized:
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
- •Patient requires mechanical circulatory support and is eligible for cardiac transplantation
- •Legal guardian and patient (if age appropriate) understands the nature of the implant procedure and are willing to comply with associated follow-up evaluations, and provide written informed consent and assent prior to the procedure
排除标准
- •Patient is currently enrolled in EXCOR® Pediatric pre-market study
- •Patient is currently participating in another investigational device or drug trial which would confound the results of the study
结局指标
主要结局
Safety
时间窗: 2 years
The primary safety objective of the EXCOR® Pediatric VAD Post-Approval Study is to demonstrate that the serious adverse event (SAE) rate in subjects implanted with the EXCOR® Pediatric in the study is not greater than the rate experienced in the IDE study.
Effectiveness
时间窗: 2 years
The primary effectiveness objective for the EXCOR® Pediatric VAD Post Approval Study is to assess the outcome following implantation of the EXCOR® Pediatric for transplant eligible children in need of mechanical circulatory support. Outcome is defined as transplant, recovery of left ventricular function or death.
次要结局
未报告次要终点