World-wide Randomization Antibiotic Envelope Infection Prevention Trial (WRAP-IT)

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.

You may be eligible for this study if you meet the following criteria:

• Conditions:
  pacemakers, defibrillators
• Age: Between 1 Years - 100 Years
• Gender: All