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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
CorMatrix
ClinicalTrials.gov Identifier:
NCT02073331
First received: February 24, 2014
Last updated: May 19, 2014
Last verified: February 2014
  Purpose

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


Condition
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

Resource links provided by NLM:


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: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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
  Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  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
CorMatrix
Investigators
Study Director: Andrew Green CorMatrix
  More Information

No publications provided

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: May 19, 2014
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
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014