NCT02073331已完成不适用
A Post Market Observational Study to Obtain Additional Information on the Use of CorMatrix ECM for Pericardial Reconstruction
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,420
- 试验地点
- 42
- 主要终点
- Proportion of Subjects With Device Related Adverse Events.
研究概览
简要总结
The objective of the study is to actively gather additional information on the use of CorMatrix ECM for pericardial reconstruction.
详细描述
Up to 100 clinical sites will enroll subjects who have received CorMatrix ECM for pericardial reconstruction.
The following clinical data will be collected at a single post-operative visit:
- Demographic information
- Pre-operative risk factors
- Surgical procedure
- Blood transfusion information, if applicable
- Chest tube placement information
- Surgical complications
- Use of anticoagulation medication
- Cardiac related procedures since surgical procedure
- Device related adverse events
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 ECM for pericardial reconstruction
- •Sign an Informed Consent
排除标准
- 未提供
结局指标
主要结局
Proportion of Subjects With Device Related Adverse Events.
时间窗: Post-op visit, after an average of 30 days
Data will be collected at the initial post-operative visit. This is a single visit study.
次要结局
未报告次要终点
研究者
研究点 (42)
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