Worldwide Randomized Antibiotic EnveloPe Infection PrevenTion Trial (WRAP-IT).

BACKGROUND

Cardiac implantable electronic device (CIED) infection is a major complication that is associated with significant morbidity and mortality. The aim of this study is to determine whether Medtronic TYRX absorbable envelope reduces the risk of CIED infection through 12 months of follow-up post procedure.

METHODS

WRAP-IT is a randomized, prospective, multi center, international, single-blinded study. Up to 7,764 subjects who are undergoing CIED generator replacement, upgrade, or revision, or a de novo CRT-D implant, will be enrolled and randomized (1:1) to receive the TYRX envelope or not. The primary endpoint is major CIED infection throughout 12 months of follow up after the procedure. Data will be analyzed with an intention to treat approach. WRAP-IT will also assess the performance of Medtronic's lead monitoring algorithms in subjects whose CIED includes a transvenous right ventricular defibrillation system.

CONCLUSIONS

WRAP-IT is a large randomized clinical trial that will assess the efficacy of TYRX absorbable envelope in reducing CIED infection, define its cost effectiveness, and will also provide a unique opportunity to better understand the pathophysiology and risk factors for CIED infection.