Comparison of Participants Who Received a CanGaroo® Envelope, TYRX™ Envelope, or no Envelope During CIED Implantation

Study Overview
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Brief Summary
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The objective of this study is to gather information on participants returning at time of CIED change-out or revision who underwent a device implantation with either a CanGaroo® envelope, TYRX™ envelope, or no envelope.

Detailed Description
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This multi-center study will enroll up to approximately 100 participants who have undergone one or more implantations of a CIED with either CanGaroo®, TYRX™, or no envelope (up to approximately 30-35 participants per cohort) and are returning for a CIED change-out or revision procedure at least 4 months or longer from their prior procedure. Once enrolled, each participant will have their medical history data collected (baseline demographics, medical history, prior CIED exchanges/revisions, and post implant clinical events). Prior to the scheduled change-out/revision procedure, there will be an assessment of the current healed implant site skin incision independently by both the participant and investigator using the Patient and Observer Scar Assessment Scale (POSAS), as well as photographs taken of the current skin scar. During the change-out/revision procedure, additional investigator assessments will include photographic documentation of CIED implant pocket lining, classification of the extent of lead adhesions in the implant pocket, and biopsies of the anterior and posterior capsule walls for histologic analysis. Procedural details and any complications/AEs that occur during the change-out/revision procedure will also be captured.

Official Title
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A Multi-Center Study Evaluating Participants Who Received CanGaroo® Envelope, TYRX™ Envelope, or No Envelope During CIED Implantation

Conditions
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Cardiac Disease

Intervention / Treatment
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* Device: CIED envelope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who previously underwent one or more prior CIED implantations utilizing a CanGaroo® envelope, TYRX™ envelope, or no envelope and are returning for a CIED change-out or revision procedure at least 4 months or longer from their prior procedure. The following possible scenarios would be eligible for enrollment: a. One prior CIED Implant: i. No envelope ii. CanGaroo® envelope iii. TYRX™ envelope b. Multiple prior CIED Implants (envelope type should remain the same for each participant throughout their implant history): i. No envelope → no envelope ii. No envelope → CanGaroo® envelope iii. No envelope → TYRX™ envelope iv. CanGaroo® envelope → CanGaroo® envelope v. TYRX™ envelope → TYRX™ envelope vi. No envelope → CanGaroo® envelope → CanGaroo® envelope vii. No envelope → no envelope → CanGaroo® envelope viii. No envelope → TYRX™ envelope → TYRX™ envelope ix. No envelope → no envelope → TYRX™ envelope Participants aged 18 years or older at time of enrollment. Participant is able and agrees to provide written informed consent and use of PHI. Participants for whom prior CIED implant history information can be obtained. Exclusion Criteria: Active infection involving the CIED implant site (clinical diagnosis of an active infection at the time of change-out/revision procedure). Participants under the age of 18 at time of enrollment. Participants with a history of multiple prior CIED implants over time using more than one type of envelope will be excluded as well as participants with a history of one type of envelope use, but the current pocket does not have an envelope. Scenarios that would be excluded: CanGaroo® envelope → TYRX™ envelope TYRX™ envelope → CanGaroo® envelope CanGaroo® envelope - no envelope TYRX™ envelope → no envelope No envelope → CanGaroo® envelope → no envelope No envelope → TYRX™ envelope → no envelope No envelope → CanGaroo® envelope → TYRX™ envelope No envelope → TYRX™ envelope → CanGaroo® envelope CanGaroo® envelope → no envelope → TYRX™ envelope TYRX™ envelope → no envelope → CanGaroo® envelope CanGaroo® envelope → TYRX™ envelope → no envelope TYRX™ envelope → CanGaroo® envelope → no envelope CanGaroo® envelope → CanGaroo® envelope → no envelope TYRX™ envelope → TYRX™ envelope → no envelope Participants undergoing a change-out or revision procedure less than 4 months from their prior procedure.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CanGaroo Envelope<br>Participants who received a CanGaroo envelope during CIED implantation | Device: CIED envelope<br>* Evaluation of the difference in cohorts for soft tissue healing surrounding the CIED implant and clinical outcomes and complications.<br>|
| TYRX Envelope<br>Participants who received a TYRX envelope during CIED implantation | Device: CIED envelope<br>* Evaluation of the difference in cohorts for soft tissue healing surrounding the CIED implant and clinical outcomes and complications.<br>|
| No Envelope<br>Participants who did not receive an envelope during CIED implantation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blinded Histologic Evaluation of Biopsies Taken from the Anterior and Posterior Capsule Wall | Microscopic analysis of cellularity, vascularity, collagen density, necrosis, infectious agents, remnant device material, giant cells, and fibrotic capsule thickness will be evaluated for each biopsy site using a quantitative scoring system with an attempt to distinguish between remnant envelope collagen (if ECM envelope was used) and neocollagen from the participant. Composite (total) and average scores will be determined based on the individual scores from each biopsy site. The quantitative thickness of each fibrotic capsule biopsy will be measured using digital image software. Four (4) thickness measurements will be performed across the image for each biopsy sample, and the average fibrotic thickness will be reported for each sample. In addition, the total average thickness across the four samples will be determined based on the average individual recordings. | Surgical Procedure Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documented CIED Complications | Comparison between cohorts of documented clinical outcomes and complications since the most recent CIED procedure through the current change-out/revision procedure. Assessment of the clinical outcomes & events of the 3 cohorts will inform on potential differences in clinical outcomes that may be related to the cohort treatment. For example: infection, Twiddler's syndrome, CIED migration, CIED erosion, lead revision, lead dislodgement, pocket revision, device reprogramming, pocket revision. | Pre-Surgery Visit |