Endpoints

Primary endpoint:

  • Composite of inappropriate shocks and ICD-related complications

Secondary endpoints:

  • All cause mortality
  • Major Adverse Cardiac Event (MACE), defined as cardiac death, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting and/or any valve surgery.
  • Appropriate shocks and patients with appropriate shocks
  • Inappropriate shocks and patients with inappropriate shocks
  • Complications individually, defined as infections, bleedings, thrombotic events, pneumothorax, perforation/tamponade, lead reposition and lead- or device failures
  • Cardiac decompensation
  • Crossovers to the other arm
  • Appropriate shock treatments in ATP or monitor zone
  • Quality of life
  • Cardiac (pre-) syncope events
  • Time to successful therapy
  • First shock conversion efficacy
  • Implant procedure time
  • Hospitalization rate
  • Fluoroscopy time