A Post Market Study on the Use of Cormatrix® Cangaroo ECM® (Extracellular Matrix) Envelope

Cardiovascular Disease Clinical Trial

— SECURE  

Official title:

A Post Market Observational Study to Obtain Additional Information on the Use of Cormatrix® Cangaroo ECM® Envelope

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02530970
• Other study ID #: 14-PR-1110
• Status: Completed
• Start date: October 2015
• Est. completion date: April 2018

Study information

• Verified date: July 2023
• Source: Aziyo Biologics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1025
• Est. completion date: April 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Locations

Country	Name	City	State
United States	Cardiology Associates	Albany	Georgia
United States	Advanced Cardiovascular, LLC	Alexander City	Alabama
United States	AnMed Health Arrhythmia Specialists	Anderson	South Carolina
United States	University of Michigan	Ann Arbor	Michigan
United States	Athens Cardiology Group	Athens	Georgia
United States	Bay Pines VA	Bay Pines	Florida
United States	Heart & Rhythm Solution	Chandler	Arizona
United States	South Carolina Heart Center	Columbia	South Carolina
United States	Sanger Heart & Vascular	Concord	North Carolina
United States	Bethesda	Delray Beach	Florida
United States	St. John Providence	Detroit	Michigan
United States	Wayne State University Physician Group	Detroit	Michigan
United States	Cardiology Institute of Michigan	Flint	Michigan
United States	Advanced Cardiovascular Clinic	Flushing	Michigan
United States	Florida Heart & Rhythm Specialists	Fort Lauderdale	Florida
United States	North Georgia Heart Foundation	Gainesville	Georgia
United States	The Queen's Medical Center	Honolulu	Hawaii
United States	HeartPlus Center	Jackson	Mississippi
United States	Baptist Heart Specialists	Jacksonville	Florida
United States	UF Health Jacksonville	Jacksonville	Florida
United States	Carolina Heart Specialists	Lancaster	South Carolina
United States	Sparrow Thoracic Cardiovascular Institute	Lansing	Michigan
United States	Little Rock VA Clinic	Little Rock	Arkansas
United States	Georgia Arrhythmia Consultants	Macon	Georgia
United States	Carolina East Heart Center	New Bern	North Carolina
United States	Cardiovascular Institute of NW Florida	Panama City	Florida
United States	Baptist Healthcare Cardiology	Pensacola	Florida
United States	Arizona Heart Rhythm Center	Phoenix	Arizona
United States	Cardiac Electrophysiology/St. Joseph	Phoenix	Arizona
United States	University of Oregon Health Science Center	Portland	Oregon
United States	NC Heart & Vascular	Raleigh	North Carolina
United States	Carolina Cardiology Clinical Research	Rock Hill	South Carolina
United States	Mercy Heart & Vascular	Rogers	Arkansas
United States	Stockton Medical Center	Stockton	California
United States	UT Health Science Center - EP Heart	The Woodlands	Texas
United States	St. Joseph Heritage Medical Group	Tustin	California
United States	Central DuPage Hospital	Winfield	Illinois
United States	Novant Health Winston-Salem Cardiology	Winston-Salem	North Carolina
United States	Wellspan Heart & Vascular	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Aziyo Biologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.