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Objective: Confirm the safety and efficacy of the BIOMONITOR III

Recruitment was stopped, number of patients recruited: 19


  • The primary aim of this study is to confirm the safety and efficacy of the BIOMONITOR III – the third generation of an implantable cardiac monitor that automatically detects and monitors heart rhythms of a patient.
  • Multi-centre, international, non-randomised, open-label, prospective study conducted across about 30 sites in Australia
  • Enrolled participants will be implanted with BIOMONITOR III, attend follow up visits and connect to BIOTRONIK Home Monitoring
  • New insertion tool called FIT OneStip will be used to implant BIOMONITOR II which will make the procedure faster and less invasive
  • Enrolment target was reached in February 2021


To be eligible for participation in the study, patients must fulfill at least one of the following four inclusion criteria:

  • Patient is at high risk of developing a clinically important cardiac arrhythmia; or
  • Patient is undergoing investigation for symptoms such as palpitations, pre-syncope or syncope, that are suggestive of an underlying cardiac arrhythmia; or
  • Patient is undergoing investigation for the detection of atrial fibrillation following cryptogenic stroke; or
  • Patient is planned for AF ablative procedure or has already undergone an AF ablative procedure.

Additionally, the following inclusion criteria must be fulfilled:

  • Patient is able to understand the nature of the clinical study and has provided written informed consent.
  • Patient is willing and able to perform the planned follow up visits at the investigation site.
  • Patient is willing and able to use the CardioMessenger device and accepts the BIOTRONIK Home Monitoring® concept.


  • Patients with implanted ICDs or pacemakers.
  • Patient is pregnant or breast-feeding.
  • Patient is less than 18 years old.
  • Patient´s life-expectancy is less than 12 months.
  • Participation in another interventional clinical investigation.