Rationale and design of the PRAETORIAN trial: A Prospective, RAndomizEd comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter-defibrillator therapy

LRAO Nordkamp, RE Knops, GH Bardy, Y Blaauw, LVA Boersma, JS Bos, PPHM Delnoy, PFHM van Dessel, AHG Driessen, JR de Groot, JPR Herrman, Luc Jordaens, KM Kooiman, AH Maass, M Meine, Y Mizusawa, SG Molhoek, J van Opstal, Kedir Adal, AAM Wilde

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129 Citations (Scopus)

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. Study Design 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 Conclusion 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. (Am Heart J 2012;163:753-760.e2.)
Original languageUndefined/Unknown
Pages (from-to)753-+
JournalAmerican Heart Journal
Volume163
Issue number5
DOIs
Publication statusPublished - 2012

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