{"id":970,"date":"2020-06-29T14:05:10","date_gmt":"2020-06-29T14:05:10","guid":{"rendered":"http:\/\/www.praetorian-trial.org\/?page_id=970"},"modified":"2020-07-02T09:18:47","modified_gmt":"2020-07-02T09:18:47","slug":"summary-of-praetorian-study-protocol","status":"publish","type":"page","link":"https:\/\/www.praetorian-trial.org\/?page_id=970","title":{"rendered":"Protocol summary"},"content":{"rendered":"

Background: <\/strong>The use of implantable cardioverter defibrillators (ICDs) is an established therapy for the prevention of death from ventricular arrhythmia1. In 2010 the entirely subcutaneous ICD Summary of PRAETORIAN STUDY PROTOCOL has been introduced, eliminating the need for transvenous lead placement in or on the heart which is mandatory in the transvenous ICD. The subcutaneous ICD already proved to be feasible and safe and is an accepted therapy in Europe2, 3. It is likely that the eliminated need for transvenous lead placement substantially reduces the implantation related complications and inappropriate shock therapies and elongates lead longevity. On the other hand it is unclear whether the lack of capability to provide antitachy\u2010pacing in the subcutaneous ICD may be a limitation for patients with monomorphic ventricular tachycardia. It is unclear until now whether the subcutaneous ICD is an adjunctive or primary therapy in patients at risk for sudden cardiac death.<\/p>\n

Objectives<\/strong>:<\/strong> PRAETORIAN will compare the subcutaneous ICD with the transvenous ICD with respect to the composite endpoint of inappropriate shocks and acute and chronic ICD\u2010related complications. Also PRAETORIAN will determine to which degree the lack of ATP function leads to more appropriate shocks in patients with a subcutaneous ICD.<\/p>\n

Study<\/strong> design: <\/strong>This is a prospective multicenter trial with a 1:1 randomisation to the transvenous or subcutaneous ICD. The mean follow\u2010up of the patients in the trial will be 48 months. With a total of 850 patients the study has 90% power to claim non\u2010inferiority of the subcutaneous ICD compared to the transvenous ICD. If non\u2010inferiority is established, statistical analysis will be done for superiority.<\/p>\n

Primary<\/strong> endpoint:<\/strong> The primary objective is to determine whether the subcutaneous ICD is non\u2010inferior to the transvenous ICD with respect to the primary composite endpoint of inappropriate shock therapy and ICD\u2010related complications.<\/p>\n

Inclusion criteria:<\/strong><\/p>\n