A Post Market Observational Study to Obtain Additional Information on the Use of CorMatrix ECM for Pericardial Reconstruction
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Coronary Disease
- 发起方
- Aziyo Biologics, Inc.
- 入组人数
- 1420
- 试验地点
- 42
- 主要终点
- Proportion of Subjects With Device Related Adverse Events.
- 状态
- 已完成
- 最后更新
- 2年前
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
研究者
入排标准
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.