NCT02530970已完成不适用
A Post Market Observational Study to Obtain Additional Information on the Use of Cormatrix® Cangaroo ECM® Envelope
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,025
- 试验地点
- 39
- 主要终点
- Proportion of Subjects With ECM Related Adverse Events
研究概览
简要总结
The objective of the SECURE Study is to actively gather additional information on the use of the CorMatrix® CanGaroo ECM® Envelope in a post market observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have received CorMatrix® CanGaroo ECM® Envelope for an implantable electronic device placement.
排除标准
- 未提供
结局指标
主要结局
Proportion of Subjects With ECM Related Adverse Events
时间窗: Participants were followed for an average of 235.0 days.
ECM related adverse events were collected at all study visits.
Number of Participants With Major Pocket Infections
时间窗: Participants were followed for an average of 235.0 days.
Incidence of major pocket infection included those with cellulitis in the region of the CIED pocket with wound dehiscence, erosion or purulent drainage, 2) deep incisional or organ/space (pocket) surgical site infection, 3) persistent bacteremia or 4) endocarditis.
次要结局
未报告次要终点
研究者
研究点 (39)
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