The objective of the study is to confirm the safety and efficacy of the BIOMONITOR III system. Furthermore, the insertion procedure, the use and handling of the incision and insertion tools and the sensing quality of the BIOMONITOR III will be assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
48
Patients with ICM indication receive a third-generation implantable cardiac monitor
HeartCare Partners - Wesley Testing
Auchenflower, Queensland, Australia
Bundaberg Cardiology
Bundaberg, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
HeartCare Victoria - Doncaster
Balwyn, Victoria, Australia
Adverse Events
(procedure / device related)
Time frame: 1 month
R-wave amplitude
Time frame: 1 month
Insertion procedure of the BIOMONITOR III by using the incision and insertion tools
Assessment of insertion procedure by using a questionaire about handling and time record.
Time frame: At the day of insertion of the BIOMONITOR III
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Mount Hospital
Perth, Western Australia, Australia
The Canberra Hospital
Canberra, Australia
The Alfred Hospital
Melbourne, Australia