World-wide Randomization Antibiotic Envelope Infection Prevention Trial (WRAP-IT)
Brief Description Of Study
This study is a single-blinded,randomized,prospective, multi-center clinical trial. The study will evaluate the ability of the TYRX absorable Antibacterial Envelope to reduce major cardiovascular implantable electronic device (CIED) infections. Patients undergoing CIED generator replacement, upgrade, revision or new biventricular defibrillator system will be randomized to receive the TYRX envelope or not to receive the TYRX envelope. A CIED is an implantable defibrillator or pacemaker.