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

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: February 24, 2014
Last updated: April 22, 2015
Last verified: April 2015
The objective of the study is to actively gather additional information on the use of CorMatrix ECM for pericardial reconstruction.

Coronary Disease

Study Type: Observational
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

Further study details as provided by CorMatrix:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 5000
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)
CorMatrix ECM
Data collection for 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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who have received CorMatrix ECM for pericardial reconstruction

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02073331

Sponsors and Collaborators
Study Director: Andrew Green CorMatrix
  More Information

Responsible Party: CorMatrix
ClinicalTrials.gov Identifier: NCT02073331     History of Changes
Other Study ID Numbers: 14-PR-1095 
Study First Received: February 24, 2014
Last Updated: April 22, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by CorMatrix:
Open heart surgery, cardiac repair

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on May 26, 2016