Obtain Additional Information on Use of CorMatrix ECM (Extracellular Matrix)
- Conditions
- Coronary Disease
- Registration Number
- NCT02073331
- Lead Sponsor
- 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1420
- Subjects who have received CorMatrix ECM for pericardial reconstruction
- Sign an Informed Consent
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of Subjects With Device Related Adverse Events. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (42)
Cardio Thoracic Vascular Surgery
🇺🇸Macon, Georgia, United States
University of Arizona Medical Center
🇺🇸Tucson, Arizona, United States
Sparrow Hospital
🇺🇸Lansing, Michigan, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Michigan Heart
🇺🇸Ypsilanti, Michigan, United States
St. Peter's Health Partners
🇺🇸Albany, New York, United States
Wake Medical
🇺🇸Raleigh, North Carolina, 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
Reid Hospital
🇺🇸Richmond, Indiana, United States
Triad Cardiac & Thoracic Surgeons
🇺🇸Greensboro, North Carolina, United States
Coastal Thoracic Surgical Associates
🇺🇸Wilmington, North Carolina, 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
Carilion Cardiothoracic Surgery
🇺🇸Roanoke, Virginia, United States
Cardiothoracic & Vascular Surgeons, PA
🇺🇸Austin, Texas, United States
David L. Galbut, MD & Associates
🇺🇸Miami, Florida, United States
Cario-Thoracic Surgeons, P.C.
🇺🇸Birmingham, Alabama, United States
Southwest Heart & Lung
🇺🇸Phoenix, Arizona, United States
TriStar Cardiovascular Surgery
🇺🇸Nashville, Tennessee, United States
Phoenix Cardiac Surgery
🇺🇸Phoenix, Arizona, United States
Community Health Network
🇺🇸Indianapolis, Indiana, United States
Henry Ford Health Systems
🇺🇸Detroit, Michigan, United States
Advanced Cardiovascular & Thoracic Surgery
🇺🇸Nashville, Tennessee, United States
Mountain Star Cardiovascular Services, LLC
🇺🇸Salt Lake City, Utah, United States
South Florida Heart & Lung Institute
🇺🇸Doral, Florida, United States
Cardiovascular Consultants, LTD
🇺🇸Glendale, Arizona, United States
Palm Beach Gardens Medical Center
🇺🇸Palm Beach Gardens, Florida, United States
Mercy Clinic Cardiac Thoracic & Vascular Surgery
🇺🇸Fort Smith, Arkansas, United States
Thoracic & Cardiovascular Associates, Inc.
🇺🇸Charleston, West Virginia, United States
Coastal Cardiovascular Surgeons
🇺🇸Panama City, Florida, United States
Tenet Florida Physician Services
🇺🇸Delray Beach, Florida, United States
Hartford Healthcare Medical Group
🇺🇸Hartford, Connecticut, United States
Southern Cardiac & Vascular Associates
🇺🇸Tallahassee, Florida, United States
Cardiothoracic & Vascular Surgical Associates
🇺🇸Jacksonville, Florida, United States
Baptist Cardiovascular Surgery
🇺🇸Jackson, Mississippi, United States
Western Michigan University Homer Stryker Medical Center School of Medicine for Clinical Research
🇺🇸Kalamazoo, Michigan, United States
Magnolia Regional
🇺🇸Corinth, Mississippi, United States
Novant Health Cardiothoracic Surgeons
🇺🇸Winston-Salem, North Carolina, United States
Baptist Medical Center
🇺🇸Little Rock, Arkansas, United States