Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT02073331
Recruitment Status : Completed
First Posted : February 27, 2014
Results First Posted : October 4, 2019
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Aziyo Biologics, Inc.

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

Condition or disease
Coronary Disease

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

Layout table for study information
Study Type : Observational
Actual Enrollment : 1420 participants
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
Study Start Date : March 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

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



Primary Outcome Measures :
  1. Proportion of Subjects With Device Related Adverse Events. [ Time Frame: Post-op visit, after an average of 30 days ]
    Data will be collected at the initial post-operative visit. This is a single visit study.



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.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
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:

  • None

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


Locations
Show Show 43 study locations
Sponsors and Collaborators
Aziyo Biologics, Inc.
Investigators
Layout table for investigator information
Study Director: Andrew Green Aziyo Biologics, Inc.
  Study Documents (Full-Text)

Documents provided by Aziyo Biologics, Inc.:
Study Protocol  [PDF] July 17, 2014
No Statistical Analysis Plan (SAP) exists for this study.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Aziyo Biologics, Inc.
ClinicalTrials.gov Identifier: NCT02073331    
Other Study ID Numbers: 14-PR-1095
First Posted: February 27, 2014    Key Record Dates
Results First Posted: October 4, 2019
Last Update Posted: February 11, 2020
Last Verified: February 2020
Keywords provided by Aziyo Biologics, Inc.:
Open heart surgery, cardiac repair
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases