Background: 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.
Objectives: 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.
Primary endpoint: Failed first shock during spontaneous episodes of fast ventricular arrhythmias (VT and VF).
Study design: 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‐up of the patients in the trial will be 40 months. A total of 965 patients will be included in the study.
- Patients must be ≥ 18 years of age
- Patients who meet current guidelines for ICD therapy and intend to undergo a de novo implant procedure for an S-ICD
- Patients must pass S-ICD screening per local routine
- Patients willing and capable of complying with follow-up visits
- Patients must be eligible for both DFT strategies per physician discretion
- Patients with life expectancy shorter than 12 months due to any medical condition
- Patients who are known to be pregnant
- Patients with intracardiac thrombus
- Patients with atrial fibrillation without appropriate anticoagulation
- Patients likely to undergo heart transplant within 12 months
- Patients with LVAD
- Patients with other contra-indications for DFT per physician’s discretion