A Post Market Study on the Use of Cormatrix® Cangaroo ECM® (Extracellular Matrix) Envelope
- Conditions
- Cardiovascular Disease
- Registration Number
- NCT02530970
- Lead Sponsor
- Aziyo Biologics, Inc.
- Brief Summary
The objective of the SECURE Study is to actively gather additional information on the use of the CorMatrix® CanGaroo ECM® Envelope in a post market observational study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1025
- Subjects who have received CorMatrix® CanGaroo ECM® Envelope for an implantable electronic device placement.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of Subjects With ECM Related Adverse Events Participants were followed for an average of 235.0 days. ECM related adverse events were collected at all study visits.
Number of Participants With Major Pocket Infections Participants were followed for an average of 235.0 days. Incidence of major pocket infection included those with cellulitis in the region of the CIED pocket with wound dehiscence, erosion or purulent drainage, 2) deep incisional or organ/space (pocket) surgical site infection, 3) persistent bacteremia or 4) endocarditis.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (39)
Bethesda
🇺🇸Delray Beach, Florida, United States
Cardiology Institute of Michigan
🇺🇸Flint, Michigan, United States
Sparrow Thoracic Cardiovascular Institute
🇺🇸Lansing, Michigan, United States
UT Health Science Center - EP Heart
🇺🇸The Woodlands, Texas, United States
NC Heart & Vascular
🇺🇸Raleigh, North Carolina, United States
South Carolina Heart Center
🇺🇸Columbia, South Carolina, United States
Stockton Medical Center
🇺🇸Stockton, California, United States
St. Joseph Heritage Medical Group
🇺🇸Tustin, California, United States
Cardiac Electrophysiology/St. Joseph
🇺🇸Phoenix, Arizona, United States
Wayne State University Physician Group
🇺🇸Detroit, Michigan, United States
University of Oregon Health Science Center
🇺🇸Portland, Oregon, United States
Advanced Cardiovascular, LLC
🇺🇸Alexander City, Alabama, United States
Heart & Rhythm Solution
🇺🇸Chandler, Arizona, United States
Little Rock VA Clinic
🇺🇸Little Rock, Arkansas, United States
Arizona Heart Rhythm Center
🇺🇸Phoenix, Arizona, United States
Mercy Heart & Vascular
🇺🇸Rogers, Arkansas, United States
Bay Pines VA
🇺🇸Bay Pines, Florida, United States
Baptist Healthcare Cardiology
🇺🇸Pensacola, Florida, United States
North Georgia Heart Foundation
🇺🇸Gainesville, Georgia, United States
Florida Heart & Rhythm Specialists
🇺🇸Fort Lauderdale, Florida, United States
Baptist Heart Specialists
🇺🇸Jacksonville, Florida, United States
Cardiovascular Institute of NW Florida
🇺🇸Panama City, Florida, United States
Cardiology Associates
🇺🇸Albany, Georgia, United States
Athens Cardiology Group
🇺🇸Athens, Georgia, United States
UF Health Jacksonville
🇺🇸Jacksonville, Florida, United States
Georgia Arrhythmia Consultants
🇺🇸Macon, Georgia, United States
St. John Providence
🇺🇸Detroit, Michigan, United States
Central DuPage Hospital
🇺🇸Winfield, Illinois, United States
Advanced Cardiovascular Clinic
🇺🇸Flushing, Michigan, United States
HeartPlus Center
🇺🇸Jackson, Mississippi, United States
Sanger Heart & Vascular
🇺🇸Concord, North Carolina, United States
Carolina East Heart Center
🇺🇸New Bern, North Carolina, United States
AnMed Health Arrhythmia Specialists
🇺🇸Anderson, South Carolina, United States
Wellspan Heart & Vascular
🇺🇸York, Pennsylvania, United States
Carolina Heart Specialists
🇺🇸Lancaster, South Carolina, United States
Carolina Cardiology Clinical Research
🇺🇸Rock Hill, South Carolina, United States
The Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Novant Health Winston-Salem Cardiology
🇺🇸Winston-Salem, North Carolina, United States