title: Worldwide Randomized Antibiotic EnveloPe Infection PrevenTion Trial (WRAP-IT).
abstract: 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.
authors.affiliation: Section of Electrophysiology and Pacing, Cleveland Clinic, Cleveland, OH. Electronic address: tarakjk@ccf.org.
authors.forename: Khaldoun G
authors.initials: KG
authors.lastname: Tarakji
authors.affiliation: The Arrhythmia Institute of Valley Health System, Manhattan, NY.
authors.forename: Suneet
authors.initials: S
authors.lastname: Mittal
authors.affiliation: Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Göteborg, Sweden.
authors.forename: Charles
authors.initials: C
authors.lastname: Kennergren
authors.affiliation: Duke Clinical Research Institute, Duke University, Durham, NC.
authors.forename: Ralph
authors.initials: R
authors.lastname: Corey
authors.affiliation: Division of Cardiology, University of Washington, Seattle, WA.
authors.forename: Jeanne
authors.initials: J
authors.lastname: Poole
authors.affiliation: Medtronic, plc Mounds View, MN.
authors.forename: Kurt
authors.initials: K
authors.lastname: Stromberg
authors.affiliation: Medtronic, plc Mounds View, MN.
authors.forename: Daniel R
authors.initials: DR
authors.lastname: Lexcen
authors.affiliation: Section of Electrophysiology and Pacing, Cleveland Clinic, Cleveland, OH.
authors.forename: Bruce L
authors.initials: BL
authors.lastname: Wilkoff
mesh_terms: D000900:Anti-Bacterial Agents; D019072:Antibiotic Prophylaxis; D001424:Bacterial Infections / Q000517:prevention & control*; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D006801:Humans; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D011446:Prospective Studies; D012107:Research Design; D016037:Single-Blind Method
chemical_list: D000900:Anti-Bacterial Agents