Obtain Additional Information on Use of CorMatrix ECM (Extracellular Matrix) (RECON)

Aziyo Biologics

Status: Completed

Conditions: Coronary Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT02073331

14-PR-1095

Details and patient eligibility

About

The objective of the study is to actively gather additional information on the use of CorMatrix ECM for pericardial reconstruction.

Full 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

Enrollment: 1,420 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who have received CorMatrix ECM for pericardial reconstruction
• Sign an Informed Consent

Exclusion criteria

• None

Trial design

1,420 participants in 1 patient group

CorMatrix ECM

Description:

Data collection for information on the use of CorMatrix ECM for pericardial reconstruction