None listed
Conditions
Brief summary
BIOMONITOR III First In Man Study aims to collect first implantation experience with a new generation of implantable cardiac monitors. BIOMONITOR III is a miniaturised version of its predecessor BIOMONITOR II which has sought to address the issue of increasing patient comfort with a smaller device, but still having all of the same diagnostic capability as BIOMONITOR II. The objective thus is to examine the ease of implant of the device by physicians, and to assess its full diagnostic capacity on patients.
Interventions
Implantation of an implantable cardiac monitor (ICM) subcutaneuously on the left side of the patient's chest/pectoral area. The device itself measures 7.5cm and is itself sterile and located inside the insertion tool. The biomonitor consists of a solid housing made of biocompatible titanium coated in silicone and a flexible silicone lead body. The implantation procedure takes less than one minute and will be performed by a medical doctor on the study. In brief, the procedure is as follows. An in
Implantation of an implantable cardiac monitor (ICM) subcutaneuously on the left side of the patient's chest/pectoral area. The device itself measures 7.5cm and is itself sterile and located inside the insertion tool. The biomonitor consists of a solid housing made of biocompatible titanium coated in silicone and a flexible silicone lead body. The implantation procedure takes less than one minute and will be performed by a medical doctor on the study. In brief, the procedure is as follows. An incision is made in the skin, whereupon the insertion tool is positioned at the specific location, and the pre-mounted biomonitor is released subcutaneuosly in the left pectoral region. 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 when experiencing a syncopal episode using a patient activator device which is supplied.
Sponsors
BIOTRONIK Australia Pty. Ltd.
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is at high risk of developing a clinically important cardiac arrhythmia; or 2. Patient is undergoing investigation for symptoms such as palpitations, pre-syncope or syncope, that are suggestive of an underlying cardiac arrhythmia; or 3. Patient is undergoing investigation for the detection of atrial fibrillation following cryptogenic stroke; or 4. Patient is planned for AF ablative procedure or has already undergone an AF ablative procedure. 5. Patient is able to understand the nature of study and has provided written informed consent 6. Patient is willing and able to perform all follow up visits at the study site 7. Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept
Exclusion criteria
1. Patients implanted with ICD or pacemaker. 2. Patient is pregnant or breast feeding. 3. Patient is less than 18 years old. 4. Patient is participating in another interventional clinical investigation 5. Patient´s life-expectancy is less than 6 months.
Outcome results
None listed