World-wide Randomized Antibiotic Envelope Infection Prevention Trial
Condition: CIED Related Infection
MeSH terms: Infections; Communicable Diseases
Intervention: TYRX™ Absorbable Antibacterial Envelope
Intervention MeSH terms: Anti-Bacterial Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 7075.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Medtronic , Inc. is sponsoring the World-wide Randomized Antibiotic Envelope Infection
      Prevention Trial (WRAP-IT), a randomized, prospective, multi-center, single blinded,
      post-market, interventional clinical study. This study will evaluate the ability of the TYRX™
      envelope to reduce major Cardiac Implantable Electronic Device (CIED) infections through
      12-months post-procedure following CIED generator replacement, upgrade, revision, or de novo
      cardiac resynchronization therapy defibrillator (CRT-D) implant. Additionally, this large
      device study provides the unique opportunity to prospectively characterize the performance of
      Medtronic's lead monitoring features in subjects whose CIED system includes a transvenous
      right ventricular (RV) defibrillation lead. Finally, the WRAP-IT study will serve as a
      post-approval study for those geographies requiring a post-approval study of the TYRX™
      envelope.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is willing to sign and date the study patient informed consent (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 cardiac implantable electronic device (CIED) and is undergoing
             implantable pulse generator (IPG) (including cardiac resynchronization therapy
             pacemaker [CRT-P]), implantable cardioverter-defibrillator (ICD) or cardiac
             resynchronization therapy defibrillator (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.