Protocol summary

Background: 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‐pacing 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.

Objectives: PRAETORIAN will compare the subcutaneous ICD with the transvenous ICD with respect to the composite endpoint of inappropriate shocks and acute and chronic ICD‐related complications. Also PRAETORIAN will determine to which degree the lack of ATP function leads to more appropriate shocks in patients with a subcutaneous ICD.

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

Primary endpoint: The primary objective is to determine whether the subcutaneous ICD is non‐inferior to the transvenous ICD with respect to the primary composite endpoint of inappropriate shock therapy and ICD‐related complications.

Inclusion criteria:

  • Patients 18 years and older
  • Patients with a class I or IIa indication for ICD therapy according to the 2006 ACC/AHA/ESC guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac

Exclusion criteria:

  • Patients with documented therapy refractory monomorphic VT
  • Patients having an indication for pacing therapy
  • Patients with VTs <170 bpm
  • Patients failing appropriate QRS/T‐wave sensing with the subcutaneous ICD ECG patient screening tool provided by Cameron Health/Boston Scientific
  • Patients with incessant VT
  • Patients who have had a previous ICD implant
  • Patients (potentially) treated with cardiac contractility modulator
  • Patients with circumstances that prevent follow‐up (no permanent home or address, transient )
  • Patients who are unable to give informed consent