Cardiovascular DiseaseSECURENCT02530970
A Post Market Study on the Use of Cormatrix® Cangaroo ECM® (Extracellular Matrix) Envelope
An observational study of Cardiovascular Disease, run by Elutia Inc. at 39 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 1,025 participants
- Where
- 39 sitesUnited States
- Study dates
- Oct 2015to Apr 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects who have received CorMatrix® CanGaroo ECM® Envelope for an implantable electronic device placement.
Who may be able to join
- Subjects who have received CorMatrix® CanGaroo ECM® Envelope for an implantable electronic device placement.
Who cannot join
- -
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Cardiology Associates
Albany, Georgia, 31701
Advanced Cardiovascular, LLC
Alexander City, Alabama, 35010
AnMed Health Arrhythmia Specialists
Anderson, South Carolina, 29621
University of Michigan
Ann Arbor, Michigan, 48109
Athens Cardiology Group
Athens, Georgia, 30606
Bay Pines VA
Bay Pines, Florida, 33744
Heart & Rhythm Solution
Chandler, Arizona, 85286
South Carolina Heart Center
Columbia, South Carolina, 29204
Sanger Heart & Vascular
Concord, North Carolina, 28025
Bethesda
Delray Beach, Florida, 33484
Wayne State University Physician Group
Detroit, Michigan, 48201
St. John Providence
Detroit, Michigan, 48236
Cardiology Institute of Michigan
Flint, Michigan, 48507
Advanced Cardiovascular Clinic
Flushing, Michigan, 48433
Florida Heart & Rhythm Specialists
Fort Lauderdale, Florida, 33308
North Georgia Heart Foundation
Gainesville, Georgia, 30501
The Queen's Medical Center
Honolulu, Hawaii, 96813
HeartPlus Center
Jackson, Mississippi, 39216
Baptist Heart Specialists
Jacksonville, Florida, 32207
UF Health Jacksonville
Jacksonville, Florida, 32209
Carolina Heart Specialists
Lancaster, South Carolina, 29720
Sparrow Thoracic Cardiovascular Institute
Lansing, Michigan, 48912
Little Rock VA Clinic
Little Rock, Arkansas, 72205
Georgia Arrhythmia Consultants
Macon, Georgia, 31201
Carolina East Heart Center
New Bern, North Carolina, 28562
Cardiovascular Institute of NW Florida
Panama City, Florida, 32401
Baptist Healthcare Cardiology
Pensacola, Florida, 32501
Cardiac Electrophysiology/St. Joseph
Phoenix, Arizona, 85006
Arizona Heart Rhythm Center
Phoenix, Arizona, 85016
University of Oregon Health Science Center
Portland, Oregon, 97239
NC Heart & Vascular
Raleigh, North Carolina, 27610
Carolina Cardiology Clinical Research
Rock Hill, South Carolina, 29732
Mercy Heart & Vascular
Rogers, Arkansas, 72758
Stockton Medical Center
Stockton, California, 95204
UT Health Science Center - EP Heart
The Woodlands, Texas, 77384
St. Joseph Heritage Medical Group
Tustin, California, 92780
Central DuPage Hospital
Winfield, Illinois, 60190
Novant Health Winston-Salem Cardiology
Winston-Salem, North Carolina, 27103
Wellspan Heart & Vascular
York, Pennsylvania, 17405
About this study
Official title: 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.
- Conditions
- Cardiovascular Disease
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects With ECM Related Adverse Events
ECM related adverse events were collected at all study visits.
Measured: 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.
Measured: Participants were followed for an average of 235.0 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,025 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elutia Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Green, Study director, Corvivo Cardiovascular, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530970
- Sponsor's protocol ID
- 14-PR-1110
- Acronym
- SECURE
- Status last verified
- Jul 2023
- First submitted
- 18 Aug 2015
- Last updated
- 21 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 36620632
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Observational Study to Obtain Additional Information on the Use of Cormatrix® Cangaroo ECM® Envelope
- ClinicalTrials.gov ID
- NCT02530970
- Acronym / sponsor ID
- SECURE / 14-PR-1110
- Conditions
- Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,025 participants (actual)
- Lead sponsor
- Elutia Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 21 Aug 2015 (estimated)
- Results
- Posted 11 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who have received CorMatrix® CanGaroo ECM® Envelope for an implantable electronic device placement.
Key inclusion criteria (1 listed)
- Subjects who have received CorMatrix® CanGaroo ECM® Envelope for an implantable electronic device placement.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of Subjects With ECM Related Adverse Events
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36620632Deering 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Green study director
Corvivo Cardiovascular, Inc.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by Elutia Inc. at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects With ECM Related Adverse Events (time frame: Participants were followed for an average of 235.0 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02530970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.