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

(2012) AMERICAN HEART JOURNAL. 163(5). p.753-760
Author
Organization
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 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. 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.
Keywords
SHOCKS, TERMINATION, RAPID VENTRICULAR-TACHYCARDIA, TOLERABILITY, PACEMAKER, EFFICACY, BURST

Citation

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MLA
Olde Nordkamp, Louise RA et al. “Rationale and Design of the PRAETORIAN Trial: a Prospective, RAndomizEd Comparison of subcuTaneOus and tRansvenous ImplANtable Cardioverter-defibrillator Therapy.” AMERICAN HEART JOURNAL 163.5 (2012): 753–760. Print.
APA
Olde Nordkamp, L. R., Knops, R. E., Bardy, G. H., Blaauw, Y., Boersma, L. V., Bos, J. S., Delnoy, P. P. H., et al. (2012). Rationale and design of the PRAETORIAN trial: a Prospective, RAndomizEd comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter-defibrillator therapy. AMERICAN HEART JOURNAL, 163(5), 753–760.
Chicago author-date
Olde Nordkamp, Louise RA, Reinoud E Knops, Gust H Bardy, Yuri Blaauw, Lucas VA Boersma, Johannes S Bos, Peter Paul HM Delnoy, et al. 2012. “Rationale and Design of the PRAETORIAN Trial: a Prospective, RAndomizEd Comparison of subcuTaneOus and tRansvenous ImplANtable Cardioverter-defibrillator Therapy.” American Heart Journal 163 (5): 753–760.
Chicago author-date (all authors)
Olde Nordkamp, Louise RA, Reinoud E Knops, Gust H Bardy, Yuri Blaauw, Lucas VA Boersma, Johannes S Bos, Peter Paul HM Delnoy, Pascal FHM van Dessel, Antoine HG Driessen, Joris R de Groot, Jean Paul R Herrman, Luc Jordaens, Kirsten M Kooiman, Alexander H Maass, Mathias Meine, Yuka Mizusawa, Sander G Molhoek, Jurjen van Opstal, Jan GP Tijssen, and Arthur AM Wilde. 2012. “Rationale and Design of the PRAETORIAN Trial: a Prospective, RAndomizEd Comparison of subcuTaneOus and tRansvenous ImplANtable Cardioverter-defibrillator Therapy.” American Heart Journal 163 (5): 753–760.
Vancouver
1.
Olde Nordkamp LR, Knops RE, Bardy GH, Blaauw Y, Boersma LV, Bos JS, et al. Rationale and design of the PRAETORIAN trial: a Prospective, RAndomizEd comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter-defibrillator therapy. AMERICAN HEART JOURNAL. 2012;163(5):753–60.
IEEE
[1]
L. R. Olde Nordkamp et al., “Rationale and design of the PRAETORIAN trial: a Prospective, RAndomizEd comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter-defibrillator therapy,” AMERICAN HEART JOURNAL, vol. 163, no. 5, pp. 753–760, 2012.
@article{8088900,
  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 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. 
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.},
  author       = {Olde Nordkamp, Louise RA and Knops, Reinoud E and Bardy, Gust H and Blaauw, Yuri and Boersma, Lucas VA and Bos, Johannes S and Delnoy, Peter Paul HM and van Dessel, Pascal FHM and Driessen, Antoine HG and de Groot, Joris R and Herrman, Jean Paul R and Jordaens, Luc and Kooiman, Kirsten M and Maass, Alexander H and Meine, Mathias and Mizusawa, Yuka and Molhoek, Sander G and van Opstal, Jurjen and Tijssen, Jan GP and Wilde, Arthur AM},
  issn         = {0002-8703},
  journal      = {AMERICAN HEART JOURNAL},
  keywords     = {SHOCKS,TERMINATION,RAPID VENTRICULAR-TACHYCARDIA,TOLERABILITY,PACEMAKER,EFFICACY,BURST},
  language     = {eng},
  number       = {5},
  pages        = {753--760},
  title        = {Rationale and design of the PRAETORIAN trial: a Prospective, RAndomizEd comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter-defibrillator therapy},
  url          = {http://dx.doi.org/10.1016/j.ahj.2012.02.012},
  volume       = {163},
  year         = {2012},
}

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