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

Completed

• 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

Study Timeline

• Study First Submitted: 2015-08-18
• Study First Submitted QC: 2015-08-20
• Study First Posted: 2015-08-21
• Study Start: 2015-10
• Primary Completion: 2017-12
• Study Completion: 2018-04
• Results First Submitted: 2020-02-17
• Results First Submitted QC: 2020-02-28
• Results First Posted: 2020-03-11
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1025

Inclusion Criteria

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

Exclusion Criteria

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.

Trial Locations

Locations (39)

Advanced Cardiovascular, LLC; 🇺🇸 Alexander City, Alabama, United States

Heart & Rhythm Solution; 🇺🇸 Chandler, Arizona, United States

Cardiac Electrophysiology/St. Joseph; 🇺🇸 Phoenix, Arizona, United States

Arizona Heart Rhythm Center; 🇺🇸 Phoenix, Arizona, United States

Little Rock VA Clinic; 🇺🇸 Little Rock, Arkansas, United States

Mercy Heart & Vascular; 🇺🇸 Rogers, Arkansas, United States

Stockton Medical Center; 🇺🇸 Stockton, California, United States

St. Joseph Heritage Medical Group; 🇺🇸 Tustin, California, United States

Bay Pines VA; 🇺🇸 Bay Pines, Florida, United States

Bethesda; 🇺🇸 Delray Beach, Florida, United States

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