A Post Market Study on the Use of Cormatrix® Cangaroo ECM® (Extracellular Matrix) Envelope
SECURE
A Post Market Observational Study to Obtain Additional Information on the Use of Cormatrix® Cangaroo ECM® Envelope
1 other identifier
observational
1,025
1 country
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2015
Typical duration for all trials
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2015
CompletedFirst Posted
Study publicly available on registry
August 21, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedResults Posted
Study results publicly available
March 11, 2020
CompletedJuly 21, 2023
July 1, 2023
2.2 years
August 18, 2015
February 17, 2020
July 19, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of Subjects With ECM Related Adverse Events
ECM related adverse events were collected at all study visits.
Participants were followed for an average of 235.0 days.
Number of Participants With Major Pocket Infections
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.
Participants were followed for an average of 235.0 days.
Eligibility Criteria
Subjects who have received CorMatrix® CanGaroo ECM® Envelope for an implantable electronic device placement.
You may qualify if:
- Subjects who have received CorMatrix® CanGaroo ECM® Envelope for an implantable electronic device placement.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elutia Inc.lead
Study Sites (39)
Advanced Cardiovascular, LLC
Alexander City, Alabama, 35010, United States
Heart & Rhythm Solution
Chandler, Arizona, 85286, United States
Cardiac Electrophysiology/St. Joseph
Phoenix, Arizona, 85006, United States
Arizona Heart Rhythm Center
Phoenix, Arizona, 85016, United States
Little Rock VA Clinic
Little Rock, Arkansas, 72205, United States
Mercy Heart & Vascular
Rogers, Arkansas, 72758, United States
Stockton Medical Center
Stockton, California, 95204, United States
St. Joseph Heritage Medical Group
Tustin, California, 92780, United States
Bay Pines VA
Bay Pines, Florida, 33744, United States
Bethesda
Delray Beach, Florida, 33484, United States
Florida Heart & Rhythm Specialists
Fort Lauderdale, Florida, 33308, United States
Baptist Heart Specialists
Jacksonville, Florida, 32207, United States
UF Health Jacksonville
Jacksonville, Florida, 32209, United States
Cardiovascular Institute of NW Florida
Panama City, Florida, 32401, United States
Baptist Healthcare Cardiology
Pensacola, Florida, 32501, United States
Cardiology Associates
Albany, Georgia, 31701, United States
Athens Cardiology Group
Athens, Georgia, 30606, United States
North Georgia Heart Foundation
Gainesville, Georgia, 30501, United States
Georgia Arrhythmia Consultants
Macon, Georgia, 31201, United States
The Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Central DuPage Hospital
Winfield, Illinois, 60190, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Wayne State University Physician Group
Detroit, Michigan, 48201, United States
St. John Providence
Detroit, Michigan, 48236, United States
Cardiology Institute of Michigan
Flint, Michigan, 48507, United States
Advanced Cardiovascular Clinic
Flushing, Michigan, 48433, United States
Sparrow Thoracic Cardiovascular Institute
Lansing, Michigan, 48912, United States
HeartPlus Center
Jackson, Mississippi, 39216, United States
Sanger Heart & Vascular
Concord, North Carolina, 28025, United States
Carolina East Heart Center
New Bern, North Carolina, 28562, United States
NC Heart & Vascular
Raleigh, North Carolina, 27610, United States
Novant Health Winston-Salem Cardiology
Winston-Salem, North Carolina, 27103, United States
University of Oregon Health Science Center
Portland, Oregon, 97239, United States
Wellspan Heart & Vascular
York, Pennsylvania, 17405, United States
AnMed Health Arrhythmia Specialists
Anderson, South Carolina, 29621, United States
South Carolina Heart Center
Columbia, South Carolina, 29204, United States
Carolina Heart Specialists
Lancaster, South Carolina, 29720, United States
Carolina Cardiology Clinical Research
Rock Hill, South Carolina, 29732, United States
UT Health Science Center - EP Heart
The Woodlands, Texas, 77384, United States
Related Publications (1)
Deering TF, Catanzaro JN, Woodard DA. Physician antibiotic hydration preferences for biologic antibacterial envelopes during cardiac implantable device procedures. Front Cardiovasc Med. 2022 Dec 22;9:1006091. doi: 10.3389/fcvm.2022.1006091. eCollection 2022.
PMID: 36620632DERIVED
MeSH Terms
Conditions
Limitations and Caveats
It was single-arm study thereby precluding the possibility of direct comparisons with a control. Also, a longer follow-up would allow for the confirmation of the long-term efficacy of the CanGaroo envelope.
Results Point of Contact
- Title
- Clinical Director
- Organization
- Aziyo Biologics, Inc.
Study Officials
- STUDY DIRECTOR
Andrew Green
Corvivo Cardiovascular, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2015
First Posted
August 21, 2015
Study Start
October 1, 2015
Primary Completion
December 1, 2017
Study Completion
April 1, 2018
Last Updated
July 21, 2023
Results First Posted
March 11, 2020
Record last verified: 2023-07