{"id":982,"date":"2020-06-29T14:39:12","date_gmt":"2020-06-29T14:39:12","guid":{"rendered":"http:\/\/www.praetorian-trial.org\/?page_id=982"},"modified":"2020-07-02T08:40:00","modified_gmt":"2020-07-02T08:40:00","slug":"summary-of-praetorian-dft-study-protocol","status":"publish","type":"page","link":"https:\/\/www.praetorian-trial.org\/?page_id=982","title":{"rendered":"Protocol summary"},"content":{"rendered":"

Background:<\/strong> Defibrillation testing (DFT) of TV-ICDs at the time of implant does not improve shock efficacy or reduce arrhythmic death. In addition, patients are also exposed to the risk of DFT related complications. During S-ICD implant, DFT is linked with mostly similar risks for complications and logistic burden for sedations as TV-ICDs. The conversion rate during DFT of S-ICD is high and the first shock efficacy for the S-ICD is similar to that of the TV-ICD. However, there are currently limited studies available on the efficacy of DFT in the S-ICD.<\/p>\n

Objectives:<\/strong> The primary objective is to determine whether the S-ICD implant without DFT (with PRAETORIAN Score) is non-inferior to the S-ICD implant with DFT.
The secondary objectives are to evaluate the PRAETORIAN score and to evaluate anesthesia protocols for implantation.<\/p>\n

Primary endpoint:<\/strong> Failed first shock during spontaneous episodes of fast ventricular arrhythmias (VT and VF).<\/p>\n

Study design:<\/strong> This is a prospective multicenter trial with a 1:1 randomisation to the S- ICD implant with DFT or S-ICD implant without DFT. The median follow\u2010up of the patients in the trial will be 40 months. A total of 965 patients will be included in the study.<\/p>\n

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