None listed
Conditions
Brief summary
BioMonitor 2 Pilot Study aims to collect first implantation experience with a new generation of implantable cardiac event recorder.
Interventions
Implantation of an implantable cardiac event recorder in the patients chest just under the skin. The implantation procedure takes less than one minute. The device remains implanted until sufficient information has been gathered for the doctor to diagnose the cardiac arrhythmia or until the battery runs out after about four years. The device automatically records a number of subcutaneous ECG episodes based on a number of cardiac rhythm related triggers (AF, VT, bradycardia etc). The patient can
Implantation of an implantable cardiac event recorder in the patients chest just under the skin. The implantation procedure takes less than one minute. The device remains implanted until sufficient information has been gathered for the doctor to diagnose the cardiac arrhythmia or until the battery runs out after about four years. The device automatically records a number of subcutaneous ECG episodes based on a number of cardiac rhythm related triggers (AF, VT, bradycardia etc). The patient can also prompt a recording by the device using a patient activator device which is supplied.
Sponsors
BIOTRONIK Australia Pty. Ltd.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient at high risk of developing a clinically important cardiac arrhythmia or undergoing investigation for symptoms suggestive of cardiac arrhythmias or detection of paroxysmal atrial fibrillation following cryptogenic stroke or patients undergoing or having undergone AF ablation
Exclusion criteria
Patients implanted with ICD or pacemaker Patient who is pregnant or breast-feeding Life expectancy of less than 6 months
Outcome results
None listed