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 CIED infections through 12-months post-procedure following CIED generator replacement, upgrade, revision, or de novo 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 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.
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
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
You CAN'T join if...
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.
University of California San Francisco UCSF Medical Center San Francisco, California, United States
Cardiovascular Consultants Heart Center Fresno, California, United States
Stanford Hospital & Clinics Stanford, California, United States
Saint Joseph's Medical Center Stockton, California, United States
Eisenhower Desert Cardiology Center Rancho Mirage, California, United States