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.
Study Type
OBSERVATIONAL
Enrollment
597
CanGaroo Envelope with Cardiac Implantable Electronic Device (CIED) implantation
TYRX Envelope with Cardiac Implantable Electronic Device (CIED) implantation
Piedmont Athens Electrophysiology
Athens, Georgia, United States
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: * CIED system removal * Any invasive procedure (e.g., pocket opened) without system removal * Treatment with antibiotic therapy if the subject is not a candidate for system removal and infection recurrence after completion of antibiotic therapy or evidence of deep infection with wound dehiscence, erosion, or purulent drainage * Death
Time frame: 12 months post procedure
Number of Participants With Pocket Related Issues Prompting an Office Visit
Any pocket related issues that prompted an office visit
Time frame: 12 months post procedure
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