An observational study in Cardiovascular Disease, sponsored by Elutia Inc.. Completed at 39 sites in United States. Per ClinicalTrials.gov, last updated 2023-07-21.
Sponsored by Elutia Inc. · Observational
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.
5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.
This study's enrollment of 1,025 is above the median of 600 across 1,524 observational studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Elutia Inc. is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects who have received CorMatrix® CanGaroo ECM® Envelope for an implantable electronic device placement.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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Proportion of Subjects With ECM Related Adverse Events
ECM related adverse events were collected at all study visits.
Time frame: 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.
Time frame: Participants were followed for an average of 235.0 days.
| Milestone | CanGaroo |
|---|---|
| Started | 1025 |
| Completed | 891 |
| Not completed | 134 |
| Withdrew: Adverse event | 8 |
| Withdrew: Lost to follow-up | 88 |
| Withdrew: Physician decision | 5 |
| Withdrew: Withdrawal by subject | 14 |
| Withdrew: Death | 6 |
| Withdrew: Hospitalization | 1 |
| Withdrew: Insurance | 2 |
| Withdrew: Explant | 2 |
| Withdrew: Change in provider | 5 |
| Withdrew: Relocation | 3 |
ECM related adverse events were collected at all study visits.
| Participants | CanGaroo |
|---|---|
| Possibly Related to CanGaroo | 14 |
| Probably Related to CanGaroo | 2 |
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 | CanGaroo |
|---|---|
| Number of Participants With Major Pocket Infections | 12 |
Collected over Participants will be followed for an expected average of 3 months. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CanGaroo | 17/1,025 (1.7%) | 40/1,025 (3.9%) | 0/1,025 (0%) |
| Event | CanGaroo |
|---|---|
| Pocket InfectionInfections and infestations | 12/1025 |
| PainGeneral disorders | 5/1025 |
| HematomaVascular disorders | 5/1025 |
| SyncopeCardiac disorders | 2/1025 |
| Superficial CellulitisSkin and subcutaneous tissue disorders | 2/1025 |
| COPD ExacerbationRespiratory, thoracic and mediastinal disorders | 2/1025 |
| Superficial CIED InfectionInfections and infestations | 2/1025 |
| Congestive Heart FailureCardiac disorders | 2/1025 |
| Heart FailureCardiac disorders | 1/1025 |
| HydropneumothoraxRespiratory, thoracic and mediastinal disorders | 1/1025 |
| Age, Categorical(Participants) | CanGaroo |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 257 |
| >=65 years | 768 |
| Age, Continuous(years) | CanGaroo |
|---|---|
| Mean | 71.9 ± 12.2 |
| Sex: Female, Male(Participants) | CanGaroo |
|---|---|
| Female | 392 |
| Male | 633 |
| Ethnicity (NIH/OMB)(Participants) | CanGaroo |
|---|---|
| Hispanic or Latino | 32 |
| Not Hispanic or Latino | 990 |
| Unknown or Not Reported | 3 |
| Race (NIH/OMB)(Participants) | CanGaroo |
|---|---|
| American Indian or Alaska Native | 7 |
| Asian | 17 |
| Native Hawaiian or Other Pacific Islander | 8 |
| Black or African American | 175 |
| White | 797 |
| More than one race | 2 |
| Unknown or Not Reported | 19 |
| Region of Enrollment(participants) | CanGaroo |
|---|---|
| United States | 1025 |
| Risk Factors for Infection(Participants) | CanGaroo |
|---|---|
| None | 103 |
| Systemic Anticoagulants | 233 |
| Chronic Steroid Use | 14 |
| Renal Insufficiency | 115 |
| Diabetes | 301 |
| Prior Device Infection | 18 |
| Peripheral Vascular Disease | 80 |
| Pocket Re-entry | 5 |
| Obesity | 387 |
| Malnutrition | 12 |
| Smoker | 121 |
| Congestive Heart Failure | 450 |
| Malignancy | 42 |
| 3 or More Leads | 28 |
| 2 or More Risk Factors | 678 |
| Other | 180 |
| Temporary Pacing | 68 |
| Device Replacement/Revision | 377 |
| IV Antibiotic Used Prior to Procedure(Participants) | CanGaroo |
|---|---|
| Yes | 938 |
| Unknown | 50 |
| No | 37 |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
The record gives a start of Oct 2015, a primary completion of Dec 2017 and a completion of Apr 2018. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2020, 2 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Elutia Inc.