Destination Therapy Post Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 47
- 主要终点
- Long-term complication free survival
研究概览
简要总结
Medtronic is sponsoring the HeartWare™ HVAD™ Destination Therapy (DT) Post Approval Study (PAS) to further confirm safety and effectiveness of the HeartWare Ventricular Assist Device System (HVAD System) when used as intended, in "real-world" clinical practice.
The Destination Therapy Post Approval Study (DT PAS) is conducted within Medtronic's Product Surveillance Platform.
详细描述
The HeartWare Destination Therapy (DT) Post Approval Study (PAS) is a prospective, observational, multi-site study. Enrollment into the DT PAS will be comprised of newly enrolled, commercial use DT patients with the HeartWare Ventricular Assist Device System (HVAD System). Patients enrolled in DT PAS will be followed for 5 years post-implant or until study closure, patient death, patient exit from the PAS (i.e., withdrawal of consent), or patient has HVAD device removed without replacement (i.e., transplant, recovery) or device is exchanged for non-HVAD. The total estimated study duration is approximately 7 years.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- •Patient is intended to receive or be treated with a HeartWare HVAD System for use as destination therapy
- •Patient is consented prior to the HVAD implant procedure
排除标准
- •Patient who is, or is expected to be inaccessible for follow-up
- •Patient with exclusion criteria required by local law
- •Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e., no required intervention that could affect interpretation of all-around product safety and or effectiveness)
- •Patient less than 18 years of age.
- •Patient with previous support by long-term mechanical circulatory support (MCS), not including temporary mechanical circulatory support.
结局指标
主要结局
Long-term complication free survival
时间窗: Implant to 2 years
Complications include death, disabling stroke, or device malfunction or failure requiring exchange, explantation or urgent transplantation.
次要结局
- Stroke severity(Occurrence of stroke to 24 weeks post-stroke)
- Rate of stroke(Implant to 2 years)
- Rate of late stroke(2 years post-implant to 5 years)