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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease

• Study Type: Observational
• Enrollment (Actual): 1025

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Alexander City, Alabama, United States, 35010
      • Advanced Cardiovascular, LLC
  • Arizona
    • Chandler, Arizona, United States, 85286
      • Heart & Rhythm Solution
    • Phoenix, Arizona, United States, 85016
      • Arizona Heart Rhythm Center
    • Phoenix, Arizona, United States, 85006
      • Cardiac Electrophysiology/St. Joseph
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Little Rock VA Clinic
    • Rogers, Arkansas, United States, 72758
      • Mercy Heart & Vascular
  • California
    • Stockton, California, United States, 95204
      • Stockton Medical Center
    • Tustin, California, United States, 92780
      • St. Joseph Heritage Medical Group
  • Florida
    • Bay Pines, Florida, United States, 33744
      • Bay Pines VA
    • Delray Beach, Florida, United States, 33484
      • Bethesda
    • Fort Lauderdale, Florida, United States, 33308
      • Florida Heart & Rhythm Specialists
    • Jacksonville, Florida, United States, 32209
      • UF Health Jacksonville
    • Jacksonville, Florida, United States, 32207
      • Baptist Heart Specialists
    • Panama City, Florida, United States, 32401
      • Cardiovascular Institute of NW Florida
    • Pensacola, Florida, United States, 32501
      • Baptist Healthcare Cardiology
  • Georgia
    • Albany, Georgia, United States, 31701
      • Cardiology Associates
    • Athens, Georgia, United States, 30606
      • Athens Cardiology Group
    • Gainesville, Georgia, United States, 30501
      • North Georgia Heart Foundation
    • Macon, Georgia, United States, 31201
      • Georgia Arrhythmia Consultants
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • The Queen's Medical Center
  • Illinois
    • Winfield, Illinois, United States, 60190
      • Central DuPage Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University Physician Group
    • Detroit, Michigan, United States, 48236
      • St. John Providence
    • Flint, Michigan, United States, 48507
      • Cardiology Institute of Michigan
    • Flushing, Michigan, United States, 48433
      • Advanced Cardiovascular Clinic
    • Lansing, Michigan, United States, 48912
      • Sparrow Thoracic Cardiovascular Institute
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • HeartPlus Center
  • North Carolina
    • Concord, North Carolina, United States, 28025
      • Sanger Heart & Vascular
    • New Bern, North Carolina, United States, 28562
      • Carolina East Heart Center
    • Raleigh, North Carolina, United States, 27610
      • NC Heart & Vascular
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health Winston-Salem Cardiology
  • Oregon
    • Portland, Oregon, United States, 97239
      • University of Oregon Health Science Center
  • Pennsylvania
    • York, Pennsylvania, United States, 17405
      • Wellspan Heart & Vascular
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • AnMed Health Arrhythmia Specialists
    • Columbia, South Carolina, United States, 29204
      • South Carolina Heart Center
    • Lancaster, South Carolina, United States, 29720
      • Carolina Heart Specialists
    • Rock Hill, South Carolina, United States, 29732
      • Carolina Cardiology Clinical Research
  • Texas
    • The Woodlands, Texas, United States, 77384
      • UT Health Science Center - EP Heart

Participation Criteria

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® CanGaroo ECM® Envelope for an implantable electronic device placement.

Description

Inclusion Criteria:

• Subjects who have received CorMatrix® CanGaroo ECM® Envelope for an implantable electronic device placement.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Aziyo Biologics, Inc.
• Investigators: Study Director: Andrew Green, CorMatrix Cardiovascular, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: August 18, 2015
• First Submitted That Met QC Criteria: August 20, 2015
• First Posted (Estimated): August 21, 2015

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

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 14-PR-1110