Retrospective Experience of CIED Implantation With Piedmont Athens Regional Electrophysiology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 597
- 试验地点
- 1
- 主要终点
- Number of Participants With Major Infection Post Procedure
研究概览
简要总结
The objective of this study is to retrospectively gather information on patients who underwent a CIED procedure with either a CanGaroo Envelope, TYRX Envelope, or no envelope.
详细描述
A single center will retrospectively review up to 700 subjects who underwent implantation of a CIED with a CanGaroo Envelope, TYRX Envelope, or no envelope. All sets of subjects enrolled will also be examined for any follow-up visits and/or adverse events that occurred up to 12 months post-surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient that had a CIED implanted with either a CanGaroo Envelope, a TYRX Envelope, or no envelope on or after March 27, 2017
排除标准
- •Any patient that had a CIED implanted with any other type of envelope
- •Any patient that had a CIED implanted prior to March 27, 2017
结局指标
主要结局
Number of Participants With Major Infection Post Procedure
时间窗: 12 months post procedure
Major CIED infections are defined as a CIED infection resulting in one or more of the following: * CIED system removal * Any invasive procedure (e.g., pocket opened) without system removal * Treatment with antibiotic therapy if the subject is not a candidate for system removal and infection recurrence after completion of antibiotic therapy or evidence of deep infection with wound dehiscence, erosion, or purulent drainage * Death
次要结局
- Number of Participants With Pocket Related Issues Prompting an Office Visit(12 months post procedure)