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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.
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| 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. |
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Inclusion Criteria:
Exclusion Criteria:
-
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Subjects who have received CorMatrix® CanGaroo ECM® Envelope for an implantable electronic device placement.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Green | Corvivo Cardiovascular, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Cardiovascular, LLC | Alexander City | Alabama | 35010 | United States | ||
| Heart & Rhythm Solution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36620632 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CanGaroo | Data collection for information on the use of CorMatrix CanGaroo ECM Envelope |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 7, 2018 |
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| Chandler |
| Arizona |
| 85286 |
| United States |
| Cardiac Electrophysiology/St. Joseph | Phoenix | Arizona | 85006 | United States |
| Arizona Heart Rhythm Center | Phoenix | Arizona | 85016 | United States |
| Little Rock VA Clinic | Little Rock | Arkansas | 72205 | United States |
| Mercy Heart & Vascular | Rogers | Arkansas | 72758 | United States |
| Stockton Medical Center | Stockton | California | 95204 | United States |
| St. Joseph Heritage Medical Group | Tustin | California | 92780 | United States |
| Bay Pines VA | Bay Pines | Florida | 33744 | United States |
| Bethesda | Delray Beach | Florida | 33484 | United States |
| Florida Heart & Rhythm Specialists | Fort Lauderdale | Florida | 33308 | United States |
| Baptist Heart Specialists | Jacksonville | Florida | 32207 | United States |
| UF Health Jacksonville | Jacksonville | Florida | 32209 | United States |
| Cardiovascular Institute of NW Florida | Panama City | Florida | 32401 | United States |
| Baptist Healthcare Cardiology | Pensacola | Florida | 32501 | United States |
| Cardiology Associates | Albany | Georgia | 31701 | United States |
| Athens Cardiology Group | Athens | Georgia | 30606 | United States |
| North Georgia Heart Foundation | Gainesville | Georgia | 30501 | United States |
| Georgia Arrhythmia Consultants | Macon | Georgia | 31201 | United States |
| The Queen's Medical Center | Honolulu | Hawaii | 96813 | United States |
| Central DuPage Hospital | Winfield | Illinois | 60190 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Wayne State University Physician Group | Detroit | Michigan | 48201 | United States |
| St. John Providence | Detroit | Michigan | 48236 | United States |
| Cardiology Institute of Michigan | Flint | Michigan | 48507 | United States |
| Advanced Cardiovascular Clinic | Flushing | Michigan | 48433 | United States |
| Sparrow Thoracic Cardiovascular Institute | Lansing | Michigan | 48912 | United States |
| HeartPlus Center | Jackson | Mississippi | 39216 | United States |
| Sanger Heart & Vascular | Concord | North Carolina | 28025 | United States |
| Carolina East Heart Center | New Bern | North Carolina | 28562 | United States |
| NC Heart & Vascular | Raleigh | North Carolina | 27610 | United States |
| Novant Health Winston-Salem Cardiology | Winston-Salem | North Carolina | 27103 | United States |
| University of Oregon Health Science Center | Portland | Oregon | 97239 | United States |
| Wellspan Heart & Vascular | York | Pennsylvania | 17405 | United States |
| AnMed Health Arrhythmia Specialists | Anderson | South Carolina | 29621 | United States |
| South Carolina Heart Center | Columbia | South Carolina | 29204 | United States |
| Carolina Heart Specialists | Lancaster | South Carolina | 29720 | United States |
| Carolina Cardiology Clinical Research | Rock Hill | South Carolina | 29732 | United States |
| UT Health Science Center - EP Heart | The Woodlands | Texas | 77384 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CanGaroo | Data collection for information on the use of CorMatrix CanGaroo ECM Envelope |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Risk Factors for Infection | Count of Participants | Participants |
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| IV Antibiotic Used Prior to Procedure | Count of Participants | Participants |
| |||||||||||||||||||||||
| Pre-Procedure Temporary Pacing | Count of Participants | Participants |
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| Surgical Glue Used in Procedure | Count of Participants | Participants |
| |||||||||||||||||||||||
| Procedure Types | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Subjects With ECM Related Adverse Events | ECM related adverse events were collected at all study visits. | Analysis population includes all study participants. | Posted | Count of Participants | Participants | Participants were followed for an average of 235.0 days. |
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| |||||||||||||||||||||||||||||||||
| 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. | Analysis population includes all study participants. | Posted | Count of Participants | Participants | Participants were followed for an average of 235.0 days. |
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Participants will be followed for an expected average of 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CanGaroo | Data collection for information on the use of CorMatrix CanGaroo ECM Envelope | 17 | 1,025 | 40 | 1,025 | 0 | 1,025 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Non-systematic Assessment |
| ||
| Heart Failure | Cardiac disorders | Non-systematic Assessment |
| ||
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Syncope | Cardiac disorders | Non-systematic Assessment |
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| Superficial Cellulitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Pocket Erosion | Surgical and medical procedures | Non-systematic Assessment |
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| Pocket Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Hematoma | Vascular disorders | Non-systematic Assessment |
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| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
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| COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Lead Issues | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Inappropriate ICD Shocks | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Palpitations & Shortness of Breath | Cardiac disorders | Non-systematic Assessment |
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| Congestive Heart Failure/Renal Failure | Cardiac disorders | Non-systematic Assessment |
| ||
| Superficial CIED Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | Non-systematic Assessment |
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| NSTEMI | Cardiac disorders | Non-systematic Assessment |
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| Seroma | Cardiac disorders | Non-systematic Assessment |
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| Congestive Heart Failure | Cardiac disorders | Non-systematic Assessment |
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It was single-arm study thereby precluding the possibility of direct comparisons with a control. Also, a longer follow-up would allow for the confirmation of the long-term efficacy of the CanGaroo envelope.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Director | Aziyo Biologics, Inc. | 470-514-4085 | clinical@aziyo.com |
| Feb 28, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Chronic Steroid Use |
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| Renal Insufficiency |
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| Diabetes |
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| Prior Device Infection |
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| Peripheral Vascular Disease |
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| Pocket Re-entry |
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| Obesity |
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| Malnutrition |
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| Smoker |
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| Congestive Heart Failure |
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| Malignancy |
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| 3 or More Leads |
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| 2 or More Risk Factors |
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| Other |
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| Temporary Pacing |
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| Device Replacement/Revision |
|
| No |
|
| Yes |
|
| Unknown |
|
| De Novo CRT-P |
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| De Novo CRT-D |
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| Pacemaker Replacement |
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| ICD Replacement |
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| CRT-P Replacement |
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| CRT-D Replacement |
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| Upgrade Pacemaker to ICD |
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| Upgrade Pacemaker to CRT-P |
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| Upgrade Pacemaker to CRT-D |
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| Upgrade ICD to CRT-D |
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| Downgrad CRT-D to ICD |
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| Lead Revision/Replacement Only |
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| Pocket Revision Only |
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