Clinical Research Trials

Key Trial Criteria

• Key Inclusion Criteria

  For a patient to be eligible for participation in this study, all of the following criteria must apply.

  • Patient meets current guideline-defined indication for de novo, primary prevention ICD or CRT-D implantation
  • Patient has non-ischemic etiology of cardiomyopathy
  • Patient is successfully implanted with a de novo BIOTRONIK ICD or CRT-D device and commercially available leads no more than 30 days prior to consent or is scheduled for de novo implantation of a BIOTRONIK ICD or CRT-D device no more than 30 days post consent
  • Patient is able to understand the nature of the study and provide informed consent
  • Patient is available for standard of care follow-up visits to occur at least yearly at the study site for to the expected 3 years of follow-up
  • Patient is willing to utilize BIOTRONIK Home Monitoring® via CardioMessenger
  • Patient age is greater than or equal to 18 years

• Key Exclusion Criteria

  A patient will not be eligible for participation in this study if any of the following criteria apply.

  • Patient meets secondary prevention ICD indication
  • Patient has ischemic etiology of cardiomyopathy
  • Patient is enrolled in any investigational cardiac device or drug trial that might significantly affect the studied outcomes
  • Patient is expected to receive heart transplantation or ventricular assist device within 1 year
  • Patient life expectancy is less than 1 year
  • Patient reports pregnancy at the time of consent