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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.

Tracking Information
First Submitted Date February 24, 2014
First Posted Date February 27, 2014
Results First Submitted Date June 26, 2019
Results First Posted Date October 4, 2019
Last Update Posted Date February 11, 2020
Study Start Date March 2014
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 10, 2019)
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.
Original Primary Outcome Measures
 (submitted: February 25, 2014)
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.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Obtain Additional Information on Use of CorMatrix ECM (Extracellular Matrix)
Official Title A Post Market Observational Study to Obtain Additional Information on the Use of CorMatrix ECM for Pericardial Reconstruction
Brief Summary The objective of the study is to actively gather additional 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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects who have received CorMatrix ECM for pericardial reconstruction
Condition Coronary Disease
Intervention Not Provided
Study Groups/Cohorts CorMatrix ECM
Data collection for information on the use of CorMatrix ECM for pericardial reconstruction
Publications * Rego A, Cheung PC, Harris WJ, Brady KM, Newman J, Still R. Pericardial closure with extracellular matrix scaffold following cardiac surgery associated with a reduction of postoperative complications and 30-day hospital readmissions. J Cardiothorac Surg. 2019 Mar 15;14(1):61. doi: 10.1186/s13019-019-0871-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 27, 2018)
1420
Original Estimated Enrollment
 (submitted: February 25, 2014)
5000
Actual Study Completion Date December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02073331
Other Study ID Numbers 14-PR-1095
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Aziyo Biologics, Inc.
Study Sponsor Aziyo Biologics, Inc.
Collaborators Not Provided
Investigators
Study Director: Andrew Green Aziyo Biologics, Inc.
PRS Account Aziyo Biologics, Inc.
Verification Date February 2020