Apogee International
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 147
- 试验地点
- 31
- 主要终点
- Major adverse events
研究概览
简要总结
Medtronic is sponsoring the Apogee International registry to further confirm safety and efficacy of the HVAD™ System when used as intended, in "real world" clinical practice and to enhance scientific understanding of the implant procedure, optimized blood pressure management, anticoagulation/ antiplatelet therapies, logfile analysis and acoustic spectrum analysis in patients receiving a Medtronic HeartWare™ HVAD™ for bridge to transplant and destination therapy indications.
详细描述
Apogee International is a prospective, non-interventional, post-market, multi-site registry, conducted within Medtronic's Product Surveillance Registry (PSR) Platform. Enrollment into Apogee International will be comprised of newly implanted, commercial use patients with the HeartWare Ventricular Assist Device System (HVAD System).
Sites selected to participate are expected to collect data in at least one of these five modules:
- Logfile Download;
- Anti-coagulation / Anti-platelet Management;
- Blood Pressure (BP) Management;
- Acoustic Spectrum Analysis;
- Infection Control
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;
- •Enrollment into Apogee International will be comprised of newly enrolled, commercial use patients with the HeartWare HVAD System;
- •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;
- •Participation is excluded by local law;
- •Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the PSR results.
结局指标
主要结局
Major adverse events
时间窗: Implant to 12 months
Major adverse events are defined to be occurrence of major infection, major bleeding, device malfunction, stroke or death.
次要结局
未报告次要终点