Cardiac Implantable Electronic Device (CIED) Antibiotic Envelope Infection Prevention Trial
Cardiac Implantable Electronic Device (CIED) 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.
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
Exclusion Criteria:
Winston-Salem, North Carolina, United States