TYRX™ Pocket Health Study

Study Overview
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Brief Summary
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Medtronic, Inc. is sponsoring the TYRX™ Pocket Health Study to evaluate the histological and morphometric parameters of the device capsule in participants who underwent a cardiovascular implantable electronic device (CIED) procedure with a TYRX™ Absorbable Antibacterial Envelope and are returning for a CIED replacement procedure.

Detailed Description
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The TYRX™ Pocket Health Study is a prospective, multi-center, single arm, post-market non-interventional study. This global study is planned to be conducted in geographies including, but not limited to, the United States (US), Canada, and Europe, at approximately 5 to 10 centers and will enroll up to 35 subjects with analyzable tissue samples. All enrolled subjects must have an existing CIED (implantable pulse generator (IPG), cardiac resynchronization therapy pacemaker (CRT-P), implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D)) that was implanted with the TYRX™ Absorbable Antibacterial Envelope and are returning for a clinically indicated CIED generator replacement without the planned addition of new or revision of existing leads.

Official Title
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TYRX™ Pocket Health Study

Conditions
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Cardiac Disease, Healing Surgical Wounds

Intervention / Treatment
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* Other: Study-required procedures include: tissue collection from device capsule, questionnaire collection, and photo collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously underwent a transvenous CIED implantation utilizing TYRX™ Absorbable Antibacterial Envelope and is returning for a CIED replacement procedure without planned addition of new or revision of existing leads at least 12 months from the prior CIED implant with use of TYRX™ Absorbable Antibacterial envelope (TYRX procedure of interest) a. Participants with history of one or two prior CIED implantation(s) at current implant site can be included, provided there was no invasive intervention to the pocket since the TYRX procedure of interest, defined by Exclusion Criteria #2 Age is ≥ 18 years (or meets age requirements per local law) at time of enrollment Procedure information from participant's TYRX procedure of interest can be obtained Date of the TYRX procedure of interest Received a TYRX™ Absorbable Antibacterial Envelope during TYRX procedure of interest Provides signed and dated authorization and/or consent per institution and local requirements Willing and able to comply with the protocol Exclusion Criteria: Active infection involving the CIED implant site (physical, clinical, or laboratory signs/symptoms consistent with an active infection at time of replacement procedure, including but not limited to pneumonia, urinary tract, cellulitis, endocarditis, or bacteremia) Prior history of requiring invasive intervention to the pocket since the TYRX procedure of interest, including but not limited to lead revisions or CIED infection Prior history of skin infection at CIED implant site since the TYRX procedure of interest Returning for a CIED extraction, system upgrade, CIED replacement with planned lead addition and/or revision, planned lead revision, or pocket revision (e.g., pocket revision due to pain) Currently has or requires a submuscular or right-sided CIED implantation, or a subcutaneous implantable cardioverter defibrillator (S-ICD) Existing Ventricular Assist Device (VAD) Currently receiving hemodialysis or peritoneal dialysis therapy Current therapy with chronic oral immunosuppressive agents or ≥ 20mg/day of Prednisone (or equivalent) Has medical condition or history that precludes participant from participation in the opinion of the Investigator (e.g., too superficial positioning of the CIED) Pregnant or breastfeeding participant or participant of childbearing potential and who is not on reliable form of birth regulation method or abstinence Legally incompetent or otherwise vulnerable Participation in another study that may potentially confound the results of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from Medtronic

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 |
| --- | --- |
| Participants with a previous TYRX™ Absorbable Antibacterial Envelope implant<br>Participants who previously underwent a transvenous CIED implantation with the market released TYRX™ Absorbable Antibacterial Envelope, used for approved indications per country/region, and are returning for a CIED replacement procedure at least 12 months from the prior CIED implantation will be evaluated in this study. | Other: Study-required procedures include: tissue collection from device capsule, questionnaire collection, and photo collection<br>* Enrolled participants will have already received the TYRX™ Absorbable Antibacterial Envelope and will be clinically indicated to have a replacement with any market-released, commercially available (in the geographies they are used) CIED and lead(s) with or without the use TYRX™ Absorbable Antibacterial Envelope, as prescribed by and used on-label by their physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphology of device capsule tissue | Measurement of capsule wall thickness (measured in millimeters, mm) in tissue sample | CIED Replacement Procedure | 
| Histology of device capsule tissue | Histopathologic examination of tissue sample for extent of fibrosis, inflammation, vascularization, calcification, and adhesions, based on ordinal scoring scale | CIED Replacement Procedure |