Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)

• All-cause mortality [ Time Frame: 27 months ] [ Designated as safety issue: Yes ]
• Number of device follow-ups [ Time Frame: 27 months ] [ Designated as safety issue: Yes ]
• Quality of life [ Time Frame: 27 months ] [ Designated as safety issue: No ]

Patients with implantable cardioverter defibrillators (ICDs) should undergo regular device follow-ups every 3 months, to verify proper ICD function. However, many follow-ups are uneventful, revealing no relevant changes related to the implanted device and in the patient's diagnostic and therapeutic status. For time and economic reasons, longer follow-up intervals are frequently used although they are not according to recommendations. This may increase the delay in detection of relevant changes in the disease and in deviations from optimal ICD therapy in the individual patients. In the newest ICDs, the essential parameters reflecting safety and appropriateness of ICD therapy (threshold, impedance, intracardiac electrogram, etc.) are transmitted via Home Monitoring on a daily basis, to an internet platform accessible by the attending physician.

In the present study, the investigators evaluate safety and efficacy of 12-month follow-up intervals in ICDs with Home Monitoring capability, as compared with conventional 3-month follow-up scheme.

• Cardiac Pacing
• Electric Countershock
• Ventricular Tachyarrhythmia

• Device: Implantable cardioverter defibrillator with Home Monitoring function
  Implantable cardioverter defibrillators can send data from its diagnostic and therapy memory via wireless Home Monitoring on a daily basis to an internet based platform, securely accessed by the attending physician
  Other Names:

  • Lumax 500/540 VR-T
  • CardioMessenger (for Home Monitoring data transmission)
• Device: Standard implantable cardioverter defibrillator
  Implantable cardioverter defibrillators used as standard devices without Home Monitoring
  Other Name: Lumax 500/540 VR-T

• Experimental: 1
  Home Monitoring
  Intervention: Device: Implantable cardioverter defibrillator with Home Monitoring function
• Active Comparator: 2
  Home Monitoring not used
  Intervention: Device: Standard implantable cardioverter defibrillator

Inclusion Criteria:

• Indication for a single-chamber implantable cardioverter-defibrillator (ICD)

Exclusion Criteria:

• Contraindication for ICD
• Indication for dual-chamber ICD or cardiac resynchronization therapy