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The objective of this study is to retrospectively gather information on patients who underwent a CIED procedure with either a CanGaroo Envelope, TYRX Envelope, or no envelope.
A single center will retrospectively review up to 700 subjects who underwent implantation of a CIED with a CanGaroo Envelope, TYRX Envelope, or no envelope. All sets of subjects enrolled will also be examined for any follow-up visits and/or adverse events that occurred up to 12 months post-surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CanGaroo Envelope | Patients who received a CanGaroo Envelope with their Cardiac Implantable Electronic Device (CIED) implantation. |
| |
| TYRX Envelope | Patients who received a TYRX Envelope with their Cardiac Implantable Electronic Device (CIED) implantation. |
| |
| No Envelope | Patients who had their Cardiac Implantable Electronic Device (CIED) implanted with no envelope. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CanGaroo Envelope | Device | CanGaroo Envelope with Cardiac Implantable Electronic Device (CIED) implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Infection Post Procedure | Major CIED infections are defined as a CIED infection resulting in one or more of the following:
| 12 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Pocket Related Issues Prompting an Office Visit | Any pocket related issues that prompted an office visit | 12 months post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Male or female patients who underwent a CIED implantation utilizing a CanGaroo Envelope hydrated in saline, a CanGaroo Envelope hydrated in an antibiotic solution, a TYRX Envelope, or no envelope.
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| Name | Affiliation | Role |
|---|---|---|
| Jerome Riebman, MD | Aziyo Biologicgs, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Piedmont Athens Electrophysiology | Athens | Georgia | 30606 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CanGaroo Envelope | Patients who received a CanGaroo Envelope with their Cardiac Implantable Electronic Device (CIED) implantation. CanGaroo Envelope: CanGaroo Envelope with Cardiac Implantable Electronic Device (CIED) implantation |
| FG001 | TYRX Envelope | Patients who received a TYRX Envelope with their Cardiac Implantable Electronic Device (CIED) implantation. TYRX Envelope: TYRX Envelope with Cardiac Implantable Electronic Device (CIED) implantation |
| FG002 | No Envelope | Patients who had their Cardiac Implantable Electronic Device (CIED) implanted with no envelope. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CanGaroo Envelope | Patients who received a CanGaroo Envelope with their CIED implantation. CanGaroo Envelope: CanGaroo Envelope with CIED implantation |
| BG001 | TYRX Envelope | Patients who received a TYRX Envelope with their CIED implantation. TYRX Envelope: TYRX Envelope with CIED implantation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Major Infection Post Procedure | Major CIED infections are defined as a CIED infection resulting in one or more of the following:
| Posted | Count of Participants | Participants | 12 months post procedure |
|
12 months post-procedure
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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 Envelope | Patients who received a CanGaroo Envelope with their CIED implantation. CanGaroo Envelope: CanGaroo Envelope with CIED implantation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Cardiac disorders | Systematic Assessment |
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The limitations of this study are its retrospective, observational nature, non-randomized design, limited duration of follow up, and single-physician design. The lack of randomization may introduce bias in the selection of patients for implantation with CIED envelopes and in the choice between CanGaroo and TYRX Envelopes. Finally, the duration of follow up may not have captured late adverse events, limiting data on longer-term outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director of Clinical Operations | Aziyo Biologics, Inc. | 470-514-4085 | clinical@aziyo.com |
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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 | Dec 2, 2020 | Mar 4, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D006333 | Heart Failure |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
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| TYRX Envelope | Device | TYRX Envelope with Cardiac Implantable Electronic Device (CIED) implantation |
|
| Subjects had both CanGaroo Envelope and TYRX Envelope used during procedure |
|
| Subjects followed long-term at different health care system |
|
| Lost to Follow-up |
|
| BG002 | No Envelope | Patients who had their CIED implanted with no envelope. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI, Continuous | Mean | Standard Deviation | kg/m² |
|
Patients who received a TYRX Envelope with their CIED implantation. TYRX Envelope: TYRX Envelope with CIED implantation |
| OG002 | No Envelope | Patients who had their CIED implanted with no envelope. |
|
|
| Secondary | Number of Participants With Pocket Related Issues Prompting an Office Visit | Any pocket related issues that prompted an office visit | Posted | Count of Participants | Participants | 12 months post procedure |
|
|
|
| 0 |
| 165 |
| 9 |
| 165 |
| 0 |
| 165 |
| EG001 | TYRX Envelope | Patients who received a TYRX Envelope with their CIED implantation. TYRX Envelope: TYRX Envelope with CIED implantation | 10 | 219 | 7 | 219 | 0 | 219 |
| EG002 | No Envelope | Patients who had their CIED implanted with no envelope. | 0 | 71 | 1 | 71 | 0 | 71 |
| Pocket Infection | Cardiac disorders | Systematic Assessment |
|
| Lead Dislodgement | Cardiac disorders | Systematic Assessment |
|
| Superficial Surgical Site Infection | Cardiac disorders | Systematic Assessment |
|
| Lead Revision | Cardiac disorders | Systematic Assessment |
|
| Hemothorax | Cardiac disorders | Systematic Assessment |
|
| Thrombosis | Cardiac disorders | Systematic Assessment |
|
| Lead Perforation | Cardiac disorders | Systematic Assessment |
|
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| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| Title | Measurements |
|---|---|
|
| Lead Dislodgement |
|
| Site Drainage |
|
| Thrombosis |
|
| Superficial Surgical Site Infection (SSI) |
|
| Lead Revision |
|
| Hemothorax |
|
| Erythema & Fever |
|