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

Abstract

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.

2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure

“…Chorych należy jednak kwalifikować ostrożnie, ponieważ podskórne defibrylatory nie zapewniają adekwatnego leczenia w przypadku bradyarytmii oraz nie mają opcji stymulacji antyarytmicznej i resynchronizującej. Spodziewanych jest więcej danych pochodzących z RCT, dotyczących bezpieczeństwa i skuteczności tej metody leczenia [258,259].…”

A Case of Inappropriate Therapies for Atrial Flutter From a Subcutaneous ICD

“…The EFFORTLESS S-ICD registry is not obligatory. The Praetorian [3] study will further clarify the role of S-ICD therapy as a potential alternative to transvenous ICDs.…”

The year in cardiology 2016: arrhythmias and cardiac implantable electronic devices

“…42 Potrebne su randomizirane studije kako bi potvrdile ove rezultate i procijenile kliničku važ-nost S-ICD uređaja tijekom dugoročnog praćenja. 43 Još uvijek mlada tehnologija S-ICD uređaja istodobno se ubrzano razvija. Novi filtar (SmartPass, dostupan za Gen 2 i Gen 2,5 EMBLEM S-ICD uređaja) uveden je ove godine kako bi smanjio rizik od pojave T-wave oversensinga u bolesnika s ugrađenim S-ICD uređajima (Theuns i sur., prikazano na HRS 2016).…”

“…42 Randomized trials are required to confirm these results and evaluate the clinical impact of S-ICD during long-term follow-up. 43 The still young technology of the S-ICD is at the same time evolving rapidly. A novel high pass filter (SmartPass, available for Gen 2 and Gen 2.5 of the EMBLEM S-ICD) was introduced this year designed to reduce the risk of T-wave oversensing in S-ICD patients (Theuns et al, presented at HRS 2016).…”