Remote Follow-up of Patients Receiving Implantable Cardioverter Defibrillator for Prophylactic Therapy
Condition: Ventricular Fibrillation; Ventricular Tachycardia
MeSH terms: Tachycardia; Tachycardia, Ventricular; Ventricular Fibrillation
Study type: Interventional
Phase: Phase 4

Summary: 
      The completed MADIT II study has shown that implantation of a cardioverter-defibrillator
      (ICD) in patients with a reduced left ventricular ejection fraction and a prior myocardial
      infarction reduces death from any cause. The probability of the first therapy due to
      ventricular tachyarrhythmia was about 34% within 3 years. With a 3-month ICD-follow-up
      scheme, as it is in the standard ICD therapy, the majority of patients is followed more
      closely than necessary with respect to anti-tachyarrhythmia ICD therapy.

      A Home Monitoring (HM) function has been integrated into several ICD models from Biotronik
      (Berlin , Germany), for close remote monitoring of ICD patients. The HM function may
      substitute in-clinic follow-up controls.

      The objective of our study is to compare a standard 3-month follow-up scheme and a 12-month
      follow-up scheme using HM in ICD recipients with the "MADIT II indications". The comparison
      should be made with respect to the difference in follow-up burden and the associated costs,
      and regarding possible impact of the remote follow-up via HM on all cause mortality,
      hospitalization, and patients' quality of life.
    

Detailed description: 
      The completed MADIT II study has shown that implantation of a cardioverter-defibrillator
      (ICD) in patients with a reduced left ventricular ejection fraction and a prior myocardial
      infarction reduces death from any cause. The probability of the 1st therapy due to
      ventricular tachyarrhythmia was about 34% within 3 years, with an increasing incidence from
      year 1 to 3. With a 3-month ICD-follow-up scheme, as it is in the standard ICD therapy, the
      majority of patients is followed more closely than necessary with respect to
      anti-tachyarrhythmia ICD therapy.

      A Home Monitoring (HM) function has been integrated into several ICD models from Biotronik
      (Berlin , Germany), for close remote monitoring of ICD patients. The HM function
      automatically transmits predefined parameters on a daily basis from the implanted devices to
      a web-based platform accessible only by registered patients' physicians. These data may
      substitute in-clinical follow-up controls.

      The objective of our study is to compare a standard 3-month follow-up scheme and a 12-month
      follow-up scheme using HM in ICD recipients with the "MADIT II indications". The comparison
      should be made with respect to the difference in follow-up burden and the associated costs,
      and regarding possible impact of the remote follow-up via HM on all cause mortality,
      hospitalization, and patients' quality of life.

      The patients should receive single- or dual-chamber ICD models with the HM function.

      The pre-hospital-discharge protocol comprises standard ICD follow-up + specific ICD
      programming, and activation of the HM function. The 1st standard follow-up visit is performed
      3 months after the pre-discharge control. At this visit the patients are randomized to 3- vs.
      12-month follow-up scheme. For the 3-month follow-up group, routine visits are scheduled at
      6, 9, 12, 15, 18, 21, 24, and 27 months after patient discharge. For the 12-month (remote)
      follow-up group, routine visits are scheduled at 15 and 27 months after discharge. In either
      group, additional visits are scheduled on patient demand, due to device or lead problems, or
      due to the following Cardio Report (Home Monitoring) findings: Elective ICD replacement
      point, the 1st shock after discharge, an ineffective shock, ineffective anti-tachycardia
      pacing, ventricular pacing impedance outside the pre-defined range, shock impedance lower
      than 25 Ohm or greater than 110 Ohm, frequent arrhythmia episodes (according to pre-specified
      criteria).
    

Intervention name(s): Implantable Cardioverter Defibrillator
Intervention type(s): Device
Intervention description(s): ICD with Biotronik Home Monitoring capability
Other intervention name(s): Lexos VR-T, Lexos DR-T, Belos DR-T, Lumos VR-T
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: prophylactic ICD therapy; home monitoring; follow-up interval; remote follow-up