Obtain Additional Information on Use of CorMatrix ECM (Extracellular Matrix) (RECON)
The objective of the study is to actively gather additional information on the use of CorMatrix ECM for pericardial reconstruction.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Post Market Observational Study to Obtain Additional Information on the Use of CorMatrix ECM for Pericardial Reconstruction|
- The endpoint is defined as the proportion of subjects with device related adverse events. [ Time Frame: Initial post operative visit only ] [ Designated as safety issue: No ]Data will be collected at the initial post-operative visit. This is a single visit study.
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Data collection for information on the use of CorMatrix ECM for pericardial reconstruction
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02073331
|Study Director:||Andrew Green||CorMatrix|