NCT01577433已完成不适用
Driveline Silicone Skin Interface (SSI) Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 15
- 主要终点
- Freedom from DL infection events at 12 months after LVAD implantation
研究概览
简要总结
The purpose of this observational registry is to determine the freedom from driveline (DL) infection events in subjects implanted with a HeartMate II LVAD in whom only the silicone portion of the DL is externalized resulting in a silicone skin interface (SSI)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Subject has signed the INTERMACS informed consent form
- •Subject has signed the SSI registry informed consent form
- •Subject age ≥ 18 years
- •Subject implanted with a HeartMate II LVAD
- •Subject in whom the full length of the velour portion of the percutaneous lead is fully kept under the skin resulting in a silicone skin interface at the skin exit site
- •In the prospective study cohort, Subject is planned to be supported with the HeartMate II LVAD for at least 12 months
- •In the retrospective study cohort, at the time of enrollment, Subject has been supported with a HeartMate II for at least 10 months
排除标准
- •In the retrospective study cohort, Subject is ongoing with long-term right heart mechanical circulatory support (RVAD)
- •In the retrospective study cohort, Subject had a post-implant sternal re-entry (for bleeding, etc.) or delayed sternal closure
- •In the retrospective study cohort, Subject is participating in any other clinical investigation related to driveline (DL) exit site that could confound the study results
- •In the prospective study cohort, Subject is participating in any other clinical investigation related to driveline (DL) exit site that could confound the study results
结局指标
主要结局
Freedom from DL infection events at 12 months after LVAD implantation
时间窗: 12 Months
次要结局
- Percentage of subjects with infection events(Month 1, 3, 6, and every six months up to 60 months post-enrollment)
- DL infection events per patient year(Month 1, 3, 6, and every 6 months up to 60 months post-enrollment)
- DL tunneling methods or other factors that might reduce risks of DL related infection events(Month 1, 3, 6, and every 6 months up to 60 months post-enrollment)
研究者
研究点 (15)
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