Confirm the safety and efficacy of the BIOMONITOR III
SYNOPSIS OF THE STUDY
- 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
- Estimated duration – from February 2020 to August 2021
- 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
INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA:
- 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.
