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

July 19, 2023 updated by: Aziyo Biologics, Inc.

A Post Market Observational Study to Obtain Additional Information on the Use of CorMatrix ECM for Pericardial Reconstruction

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

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

1420

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • Cario-Thoracic Surgeons, P.C.
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Cardiovascular Consultants, Ltd
      • Phoenix, Arizona, United States, 85016
        • Phoenix Cardiac Surgery
      • Phoenix, Arizona, United States, 85028
        • Southwest Heart & Lung
      • Tucson, Arizona, United States, 85724
        • University of Arizona Medical Center
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Mercy Clinic Cardiac Thoracic & Vascular Surgery
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Heart Hospital
      • Little Rock, Arkansas, United States, 72205
        • Baptist Medical Center
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Heart Hospital
    • California
      • Rancho Mirage, California, United States, 92270
        • Heart & Lung Surgical Specialties
      • Stockton, California, United States, 95204
        • Stockton Cardiothoracic Surgical Medical Group
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Hartford HealthCare Medical Group
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Tenet Florida Physician Services
      • Doral, Florida, United States, 33166
        • South Florida Heart & Lung Institute
      • Jacksonville, Florida, United States, 32207
        • Cardiothoracic & Vascular Surgical Associates
      • Miami, Florida, United States, 33137
        • David L. Galbut, MD & Associates
      • Palm Beach Gardens, Florida, United States, 33410
        • Palm Beach Gardens Medical Center
      • Panama City, Florida, United States, 32401
        • Coastal Cardiovascular Surgeons
      • Tallahassee, Florida, United States, 32308
        • Southern Cardiac & Vascular Associates
    • Georgia
      • Macon, Georgia, United States, 31201
        • Cardio Thoracic Vascular Surgery
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Community Health Network
      • Richmond, Indiana, United States, 47374
        • Reid Hospital
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health Systems
      • Kalamazoo, Michigan, United States, 49048
        • Western Michigan University Homer Stryker Medical Center School of Medicine for Clinical Research
      • Lansing, Michigan, United States, 48912
        • Sparrow Hospital
      • Ypsilanti, Michigan, United States, 48197
        • Michigan Heart
    • Mississippi
      • Corinth, Mississippi, United States, 38834
        • Magnolia Regional
      • Jackson, Mississippi, United States, 39202
        • Baptist Cardiovascular Surgery
    • New York
      • Albany, New York, United States, 12208
        • St. Peter's Health Partners
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Triad Cardiac & Thoracic Surgeons
      • Raleigh, North Carolina, United States, 27610
        • Wake Medical
      • Wilmington, North Carolina, United States, 28401
        • Coastal Thoracic Surgical Associates
      • Winston-Salem, North Carolina, United States, 27104
        • Novant Health Cardiothoracic Surgeons
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • TriStar Cardiovascular Surgery
      • Nashville, Tennessee, United States, 37207
        • Advanced Cardiovascular & Thoracic Surgery
    • Texas
      • Austin, Texas, United States, 78756
        • Cardiothoracic & Vascular Surgeons, PA
      • Corpus Christi, Texas, United States, 78404
        • Cardiothoracic Associates
      • Denton, Texas, United States, 76210
        • Tung H. Cai, MD, PA
      • Shenandoah, Texas, United States, 77381
        • KPS Cardiovascular Surgery
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Mountain Star Cardiovascular Services, LLC
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Carilion Cardiothoracic Surgery
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Thoracic & Cardiovascular Associates, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects who have received CorMatrix ECM for pericardial reconstruction

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post-op visit, after an average of 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aziyo Biologics, Inc.

Investigators

  • Study Director: Andrew Green, Aziyo Biologics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

February 25, 2014

First Posted (Estimated)

February 27, 2014

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-PR-1095

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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