Clinical trial NCT02530970: A Post Market Study on the Use of Cormatrix® Cangaroo ECM® (Extracellular Matrix) Envelope
Official title: A Post Market Observational Study to Obtain Additional Information on the Use of Cormatrix® Cangaroo ECM® Envelope
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Lead sponsor: Elutia Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-21
Enrollment: 1025
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have received CorMatrix® CanGaroo ECM® Envelope for an implantable electronic device placement.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Proportion of Subjects With ECM Related Adverse Events
timeFrame: Participants were followed for an average of 235.0 days.
measure: Number of Participants With Major Pocket Infections
timeFrame: Participants were followed for an average of 235.0 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Alexander City
country: United States
facility: Advanced Cardiovascular, LLC
state: Alabama
city: Chandler
country: United States
facility: Heart & Rhythm Solution
state: Arizona
city: Phoenix
country: United States
facility: Cardiac Electrophysiology/St. Joseph
state: Arizona
city: Phoenix
country: United States
facility: Arizona Heart Rhythm Center
state: Arizona
city: Little Rock
country: United States
facility: Little Rock VA Clinic
state: Arkansas
city: Rogers
country: United States
facility: Mercy Heart & Vascular
state: Arkansas
city: Stockton
country: United States
facility: Stockton Medical Center
state: California
city: Tustin
country: United States
facility: St. Joseph Heritage Medical Group
state: California
city: Bay Pines
country: United States
facility: Bay Pines VA
state: Florida
city: Delray Beach
country: United States
facility: Bethesda
state: Florida
city: Fort Lauderdale
country: United States
facility: Florida Heart & Rhythm Specialists
state: Florida
city: Jacksonville
country: United States
facility: Baptist Heart Specialists
state: Florida
city: Jacksonville
country: United States
facility: UF Health Jacksonville
state: Florida
city: Panama City
country: United States
facility: Cardiovascular Institute of NW Florida
state: Florida
city: Pensacola
country: United States
facility: Baptist Healthcare Cardiology
state: Florida
city: Albany
country: United States
facility: Cardiology Associates
state: Georgia
city: Athens
country: United States
facility: Athens Cardiology Group
state: Georgia
city: Gainesville
country: United States
facility: North Georgia Heart Foundation
state: Georgia
city: Macon
country: United States
facility: Georgia Arrhythmia Consultants
state: Georgia
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
city: Winfield
country: United States
facility: Central DuPage Hospital
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Wayne State University Physician Group
state: Michigan
city: Detroit
country: United States
facility: St. John Providence
state: Michigan
city: Flint
country: United States
facility: Cardiology Institute of Michigan
state: Michigan
city: Flushing
country: United States
facility: Advanced Cardiovascular Clinic
state: Michigan
city: Lansing
country: United States
facility: Sparrow Thoracic Cardiovascular Institute
state: Michigan
city: Jackson
country: United States
facility: HeartPlus Center
state: Mississippi
city: Concord
country: United States
facility: Sanger Heart & Vascular
state: North Carolina
city: New Bern
country: United States
facility: Carolina East Heart Center
state: North Carolina
city: Raleigh
country: United States
facility: NC Heart & Vascular
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Winston-Salem Cardiology
state: North Carolina
city: Portland
country: United States
facility: University of Oregon Health Science Center
state: Oregon
city: York
country: United States
facility: Wellspan Heart & Vascular
state: Pennsylvania
city: Anderson
country: United States
facility: AnMed Health Arrhythmia Specialists
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Heart Center
state: South Carolina
city: Lancaster
country: United States
facility: Carolina Heart Specialists
state: South Carolina
city: Rock Hill
country: United States
facility: Carolina Cardiology Clinical Research
state: South Carolina
city: The Woodlands
country: United States
facility: UT Health Science Center - EP Heart
state: Texas
Study officials:
affiliation: CorMatrix Cardiovascular, Inc.
name: Andrew Green
role: STUDY_DIRECTOR
References: