World-wide Randomized Antibiotic Envelope Infection Prevention Trial

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.

Stanford is currently not accepting patients for this trial.

Intervention(s):

  • device: TYRX™ Absorbable Antibacterial Envelope

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting

Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation,  mobile application development, and pharmaceutical trials.  

Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.