NCT02073331CompletedNot Applicable
A Post Market Observational Study to Obtain Additional Information on the Use of CorMatrix ECM for Pericardial Reconstruction
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Aziyo Biologics, Inc.
- Enrollment
- 1,420
- Locations
- 42
- Primary Endpoint
- Proportion of Subjects With Device Related Adverse Events.
Study Overview
Brief Summary
The objective of the study is to actively gather additional information on the use of CorMatrix ECM for pericardial reconstruction.
Detailed Description
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects who have received CorMatrix ECM for pericardial reconstruction
- •Sign an Informed Consent
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Proportion of Subjects With Device Related Adverse Events.
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (42)
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