World-wide Randomized Antibiotic Envelope Infection Prevention Trial

Inclusion Criteria:

- Patient is willing to sign and date the study PIC form

- Patient is at least 18 years of age and meets age requirements per local law

- Patient is planned to undergo at least one of the following:

a. Patient has existing CIED and is undergoing IPG (including CRT-P), ICD or CRT-D
replacement or upgrade with a new Medtronic generator

i. Subjects planned to have leads added, or extracted and added for upgrades can be
enrolled OR

b. Patient will undergo a de novo Medtronic CRT-D system implant per approved
indications

OR

c. Patient has existing study eligible Medtronic CIED in which the pocket was not accessed
within the last 365 days, and is undergoing pocket or lead revision

- Willing to provide the contact information for the physician who provides followup for
his/her CIED

- Willing and able to comply with scheduled follow-up and study related activities

Exclusion Criteria:

- Known allergy to minocycline or rifampin or their derivatives, or any other known
contraindications to implantation of the TYRX envelope.

- Current therapy with chronic oral immunosuppressive agents or ≥ 20mg/day of Prednisone
or equivalent.

- Hemodialysis or peritoneal dialysis.

- Prior Cardiac transplantation or existing Ventricular Assist Device (VAD).

- Require long-term vascular access for any reason.

- Prior history of a CIED infection, other prosthetic device infection, or endovascular
infection, including endocarditis, in the past 12 months.

- Physical, clinical, or laboratory signs or symptoms consistent with an active
infection (including but not limited to pneumonia, urinary tract, cellulitis, or
bacteremia)

- Systemic lupus erythematous, because minocycline has been reported to aggravate this
condition

- Female patient who is pregnant, or of childbearing potential and not on a reliable
form of birth control. Women of childbearing potential are required to have a negative
pregnancy test within 7 days prior to device procedure

- Participation in another study that may confound the results of this study.
Co-enrollment in concurrent trials is only allowed when documented pre-approval is
obtained from the Medtronic study manager.