Trials / Completed
CompletedNCT02073331
Obtain Additional Information on Use of CorMatrix ECM (Extracellular Matrix)
A Post Market Observational Study to Obtain Additional Information on the Use of CorMatrix ECM for Pericardial Reconstruction
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,420 (actual)
- Sponsor
- Elutia Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Conditions
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2017-12-01
- Completion
- 2017-12-01
- First posted
- 2014-02-27
- Last updated
- 2023-07-21
- Results posted
- 2019-10-04
Locations
43 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02073331. Inclusion in this directory is not an endorsement.