Safety and Performance of INVICTA Ventricular DF4 LEADS With Active Fixation-(APOLLO)

Prior treatment

• Previous implant of pacemaker, ICD or CRT-D device and leads
• Currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study
• Drug addiction or abuse

Other illness

• Tricuspid valvular disease or any type of tricuspid replacement heart valve (mechanical or tissue)
• Transient tachyarrhythmias due to reversible causes (such as drug intoxication, electrolyte imbalance, sepsis, hypoxia or other factors as myocardial infarction or electric shock)

Lab values

• Contraindication to a maximum single dose of 330 µg dexamethasone sodium phosphate (DSP)

Other

• Active myocarditis
• Incapacitated subject or under guardianship, inability to understand the purpose of the study, or to meet follow-up visits at the implanting centre as defined in the investigational plan
• Minor subjects
• Pre-menopausal women
• Life expectancy less than 1 year

• Any patient presenting an ICD or CRT-D indication as detailed in the latest ESC guidelines
• Scheduled for a de-novo implant of an ICD (VR, DR) or CRT-D, manufactured by MicroPort CRM and equipped with a DF4 connector
• Signed and dated informed consent