title: Rationale and design of the PRAETORIAN trial: a Prospective, RAndomizEd comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter-defibrillator therapy.
abstract: BACKGROUND
  Implantable cardioverter-defibrillators (ICDs) are widely used to prevent fatal outcomes associated with life-threatening arrhythmic episodes in a variety of cardiac diseases. These ICDs rely on transvenous leads for cardiac sensing and defibrillation. A new entirely subcutaneous ICD overcomes problems associated with transvenous leads. However, the role of the subcutaneous ICD as an adjunctive or primary therapy in patients at risk for sudden cardiac death is unclear.
  
  
  METHODS
  The PRAETORIAN trial is an investigator-initiated, randomized, controlled, multicenter, prospective 2-arm trial that outlines the advantages and disadvantages of the subcutaneous ICD. Patients with a class I or IIa indication for ICD therapy without an indication for bradypacing or tachypacing are included. A total of 700 patients are randomized to either the subcutaneous or transvenous ICD (1:1). The study is powered to claim noninferiority of the subcutaneous ICD with respect to the composite primary endpoint of inappropriate shocks and ICD-related complications. After noninferiority is established, statistical analysis is done for potential superiority. Secondary endpoint comparisons of shock efficacy and patient mortality are also made.
  
  
  CONCLUSIONS
  The PRAETORIAN trial is a randomized trial that aims to gain scientific evidence for the use of the subcutaneous ICD compared with the transvenous ICD in a population of patients with conventional ICD with respect to major ICD-related adverse events. This trial is registered at ClinicalTrials.gov with trial ID NCT01296022.
authors.affiliation: Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Louise R A
authors.initials: LR
authors.lastname: Olde Nordkamp
authors.forename: Reinoud E
authors.initials: RE
authors.lastname: Knops
authors.forename: Gust H
authors.initials: GH
authors.lastname: Bardy
authors.forename: Yuri
authors.initials: Y
authors.lastname: Blaauw
authors.forename: Lucas V A
authors.initials: LV
authors.lastname: Boersma
authors.forename: Johannes S
authors.initials: JS
authors.lastname: Bos
authors.forename: Peter Paul H M
authors.initials: PP
authors.lastname: Delnoy
authors.forename: Pascal F H M
authors.initials: PF
authors.lastname: van Dessel
authors.forename: Antoine H G
authors.initials: AH
authors.lastname: Driessen
authors.forename: Joris R
authors.initials: JR
authors.lastname: de Groot
authors.forename: Jean Paul R
authors.initials: JP
authors.lastname: Herrman
authors.forename: Luc J L M
authors.initials: LJ
authors.lastname: Jordaens
authors.forename: Kirsten M
authors.initials: KM
authors.lastname: Kooiman
authors.forename: Alexander H
authors.initials: AH
authors.lastname: Maass
authors.forename: Mathias
authors.initials: M
authors.lastname: Meine
authors.forename: Yuka
authors.initials: Y
authors.lastname: Mizusawa
authors.forename: Sander G
authors.initials: SG
authors.lastname: Molhoek
authors.forename: Jurjen
authors.initials: J
authors.lastname: van Opstal
authors.forename: Jan G P
authors.initials: JG
authors.lastname: Tijssen
authors.forename: Arthur A M
authors.initials: AA
authors.lastname: Wilde
mesh_terms: D018592:Cross-Over Studies; D016757:Death, Sudden, Cardiac / Q000517:prevention & control; D017147:Defibrillators, Implantable; D004311:Double-Blind Method; D004562:Electrocardiography; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D006323:Heart Arrest / Q000401:mortality / Q000628:therapy*; D006329:Heart Conduction System / Q000503:physiopathology; D006801:Humans; D008297:Male; D011446:Prospective Studies; D018570:Risk Assessment; D015996:Survival Rate; D017180:Tachycardia, Ventricular / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D016896:Treatment Outcome