Obtain Additional Information on Use of CorMatrix ECM (Extracellular Matrix)
NCT ID: NCT02073331
Last Updated: 2023-07-21
Study Results
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View full resultsBasic Information
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COMPLETED
1420 participants
OBSERVATIONAL
2014-03-31
2017-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CorMatrix ECM
Data collection for information on the use of CorMatrix ECM for pericardial reconstruction
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Sign an Informed Consent
Exclusion Criteria
ALL
No
Sponsors
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Elutia Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew Green
Role: STUDY_DIRECTOR
Elutia Inc.
Locations
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Cario-Thoracic Surgeons, P.C.
Birmingham, Alabama, United States
Cardiovascular Consultants, LTD
Glendale, Arizona, United States
Phoenix Cardiac Surgery
Phoenix, Arizona, United States
Southwest Heart & Lung
Phoenix, Arizona, United States
University of Arizona Medical Center
Tucson, Arizona, United States
Mercy Clinic Cardiac Thoracic & Vascular Surgery
Fort Smith, Arkansas, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Baptist Medical Center
Little Rock, Arkansas, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Heart & Lung Surgical Specialties
Rancho Mirage, California, United States
Stockton Cardiothoracic Surgical Medical Group
Stockton, California, United States
Hartford Healthcare Medical Group
Hartford, Connecticut, United States
Tenet Florida Physician Services
Delray Beach, Florida, United States
South Florida Heart & Lung Institute
Doral, Florida, United States
Cardiothoracic & Vascular Surgical Associates
Jacksonville, Florida, United States
David L. Galbut, MD & Associates
Miami, Florida, United States
Palm Beach Gardens Medical Center
Palm Beach Gardens, Florida, United States
Coastal Cardiovascular Surgeons
Panama City, Florida, United States
Southern Cardiac & Vascular Associates
Tallahassee, Florida, United States
Cardio Thoracic Vascular Surgery
Macon, Georgia, United States
Community Health Network
Indianapolis, Indiana, United States
Reid Hospital
Richmond, Indiana, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Henry Ford Health Systems
Detroit, Michigan, United States
Western Michigan University Homer Stryker Medical Center School of Medicine for Clinical Research
Kalamazoo, Michigan, United States
Sparrow Hospital
Lansing, Michigan, United States
Michigan Heart
Ypsilanti, Michigan, United States
Magnolia Regional
Corinth, Mississippi, United States
Baptist Cardiovascular Surgery
Jackson, Mississippi, United States
St. Peter's Health Partners
Albany, New York, United States
Triad Cardiac & Thoracic Surgeons
Greensboro, North Carolina, United States
Wake Medical
Raleigh, North Carolina, United States
Coastal Thoracic Surgical Associates
Wilmington, North Carolina, United States
Novant Health Cardiothoracic Surgeons
Winston-Salem, North Carolina, United States
TriStar Cardiovascular Surgery
Nashville, Tennessee, United States
Advanced Cardiovascular & Thoracic Surgery
Nashville, Tennessee, United States
Cardiothoracic & Vascular Surgeons, PA
Austin, Texas, United States
Cardiothoracic Associates
Corpus Christi, Texas, United States
Tung H. Cai, MD, PA
Denton, Texas, United States
KPS Cardiovascular Surgery
Shenandoah, Texas, United States
Mountain Star Cardiovascular Services, LLC
Salt Lake City, Utah, United States
Carilion Cardiothoracic Surgery
Roanoke, Virginia, United States
Thoracic & Cardiovascular Associates, Inc.
Charleston, West Virginia, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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14-PR-1095
Identifier Type: -
Identifier Source: org_study_id
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