Ensayos clínicos

Inclusion Criteria

• Willing to sign and date the study patient informed consent form
• At least 18 years of age and meets age requirements per local law
• Planned to undergo at least one of the following
  • Has existing cardiovascular implantable electronic device and is undergoing IPG (including CRT-P), ICD or CRT-D replacement or upgrade with a new Medtronic generator is planned to have leads added, or extracted ,or upgrades can be enrolled 
  • Will undergo a new Medtronic CRT-D system implant per approved indications
  • had 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
• 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
  • Coenrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager