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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02073331
First Posted: February 27, 2014
Last Update Posted: January 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aziyo Biologics, Inc.
  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

Further study details as provided by Aziyo Biologics, Inc.:

Primary Outcome Measures:
  • The endpoint is defined as the proportion of subjects with device related adverse events. [ Time Frame: Initial post operative visit only ]
    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 2017
Estimated Primary Completion Date: June 2017 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02073331


Sponsors and Collaborators
Aziyo Biologics, Inc.
Investigators
Study Director: Andrew Green Aziyo Biologics, Inc.
  More Information

Responsible Party: Aziyo Biologics, Inc.
ClinicalTrials.gov Identifier: NCT02073331     History of Changes
Other Study ID Numbers: 14-PR-1095
First Submitted: February 24, 2014
First Posted: February 27, 2014
Last Update Posted: January 31, 2017
Last Verified: January 2017

Keywords provided by Aziyo Biologics, Inc.:
Open heart surgery, cardiac repair

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