A PRospective, rAndomizEd Comparison of subcuTaneOous and tRansvenous ImplANtable Cardioverter Defibrillator Therapy (PRAETORIAN)

• Number of Major Adverse Cardiac Event (MACE) [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  MACE is defined as cardiac death, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting and/or any valve surgery
• Number of appropriate shocks [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  An appropriate shock is shock therapy for ventricular fibrillation or ventricular tachycardia.
• Number of inappropriate shocks [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  Inappropriate shocks are defined as above.
• Number of complications individually [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  Complications are defined as above.
• Quality of life [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  The quality of life is measured by the SF-36 and Duke Activity Status Index questionnaires.
• Time to successful therapy [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  Time to successful therapy is the time between the start of VT or VF until the first successful shock or first successful ATP episode. This includes the time of sensing and charging.
• First shock conversion efficacy [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  First shock conversion efficacy is the amount of patients with VT or VF who are successfully converted with the first shock given by the transvenous ICD or subcutaneous ICD.
• Implant procedure time [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  Implant procedure time is the time between the first incision and placement of the last suture (skin-to-skin time).
• Hospitalization rate [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  The hospitalization rate is the number of days a patient is admitted to the hospital associated with ICD implantation.
• Fluoroscopy time [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  Fluoroscopy time is the total time that fluoroscopy is used during the implantation of either the transvenous ICD or subcutaneous ICD.
• Cardiac (pre-)syncope events [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  Cardiac syncope is a loss of consciousness due to cerebral hypoperfusion caused by cardiac arrhythmias or presumed cardiac arrhythmias
• Cross-overs to the other arm [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  A crossover to the other arm is defined as a patient who for any reason after randomization is switched to the other ICD arm

• Number of Major Adverse Cardiac Event (MACE) [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  MACE is defined as cardiac death, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting and/or any valve surgery
• Number of appropriate shocks [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  An appropriate shock is shock therapy for ventricular fibrillation or ventricular tachycardia.
• Number of inappropriate shocks [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  Inappropriate shocks are defined as above.
• Number of complications individually [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  Complications are defined as above.
• Quality of life [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  The quality of life is measured by the SF-36 and Duke Activity Status Index questionnaires.
• Time to therapy [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  Time to therapy is the time between the start of VT or VF until the first shock. This includes the time of sensing and charging.
• First shock conversion efficacy [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  First shock conversion efficacy is the amount of patients with VT or VF who are successfully converted with the first shock given by the transvenous ICD or subcutaneous ICD.
• Implant procedure time [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  Implant procedure time is the time between the first incision and placement of the last suture (skin-to-skin time).
• Hospitalization rate [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  The hospitalization rate is the number of days a patient is admitted to the hospital associated with ICD implantation.
• Fluoroscopy time [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  Fluoroscopy time is the total time that fluoroscopy is used during the implantation of either the transvenous ICD or subcutaneous ICD.

This randomized controlled trial will outline the advantages and disadvantages of the subcutaneous implantable cardioverter defibrillator (ICD) compared to the transvenous ICD.

Background of the study: The use of implantable cardioverter defibrillators (ICDs) is an established therapy for the prevention of death from ventricular arrhythmia. Recently a new subcutaneous ICD has been introduced, eliminating the need for transvenous lead placement in or on the heart which is mandatory in the transvenous ICD. The new subcutaneous ICD therapy already proved to be feasible and safe and is an approved therapy in Europe. It is likely that the eliminated need for transvenous lead placement substantially reduces the implantation related complications and elongates lead longevity and thus reduces inappropriate shocks associated with lead fractures. On the other hand it is unclear whether the lack of capability to provide antitachy-pacing (ATP) in the subcutaneous ICD may be a limitation for patients with frequent recurrent ventricular tachycardia. This randomized controlled trial will outline the advantages and disadvantages of the subcutaneous ICD.

Objectives of the study: (1) To compare the subcutaneous ICD to the transvenous ICD for major adverse events (i.e. inappropriate shocks, acute and chronic implant related complications and lead- or device related complications). (2) To determine to which degree the lack of ATP function leads to more appropriate shocks in patients with a subcutaneous ICD.

Study design: Multicenter, prospective, randomized controlled trial with either treatment with the transvenous ICD or subcutaneous ICD (1:1).

Study population: 2x350 patients with class I or IIa indication for ICD therapy without an indication for pacing.

• Device: Implantation of subcutaneous ICD
  Implantation of subcutaneous ICD
• Device: Implantation of transvenous ICD
  Implantation of transvenous ICD

• Active Comparator: Subcutaneous ICD
  Subcutaneous Implantable Cardioverter Defibrillator
  Intervention: Device: Implantation of subcutaneous ICD
• Active Comparator: Transvenous ICD
  Transvenous Implantable Cardioverter Defibrillator
  Intervention: Device: Implantation of transvenous ICD

Inclusion Criteria:

• Patients 18 years and older
• Patients with class I or IIa indication for ICD therapy according to the ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death

Exclusion Criteria:

• Patients with documented therapy refractory monomorphic ventricular tachycardia
• Patients having an indication for pacing therapy
• Patients with ventricular tachycardia less than 170 bpm
• Patients failing appropriate QRS/T-wave sensing with the S-ICD ECG patient screening tool provided by Cameron Health
• Patients with incessant ventricular tachycardia
• Patients with a serious known concomitant disease with a life expectancy of less than one year
• Patients with circumstances that prevent follow-up (no permanent home or address, transient, etc.)
• Patients who are unable to give informed consent