Key Results
Key Result 1
BIOMONITOR III shows a high and stable R-wave amplitude
BIO|CONCEPT.BIOMONITOR III Clinical Trial
Miniaturized implantable cardiac monitor with a long sensing vector (BIOMONITOR III): Insertion procedure assessment, sensing performance, and home monitoring transmission success
MARIANI J ET AL.,JOURNAL OF ELECTROCARDIOLOGY 2020
Study Design
- Prospective, open-label, non-randomized, multicenter study
- 48 patients implanted with a BIOMONITOR III, using the FIT OneStep insertion tool at 10 sites in Australia
- Follow-up one week (on-site) and one month (Home Monitoring) after implantation
- To confirm the safety and efficacy of the insertion procedure and of the use and handling of the incision/insertion tools, and to assess the sensing quality of BIOMONITOR III
Key Result 2
Clearly visible P-waves in the vast majority of patients
Key Result 3
BIOMONITOR III shows good usability and is easy to handle
Clinical Relevance
- Implantable Cardiac Monitors (ICM) are helpful in the diagnosis of a wide range of rare disorders and pathologies.
- Remote monitoring capabilities of ICMs improve the time to diagnosis and the follow-up strategy and offer a potential reduction of health care costs.
- The Bio|Concept study data confirmed the safety, efficacy and sensing quality of BIOMONITOR III.
Study Details
Study Objective
- To confirm the safety and efficacy of the insertion procedure and of the use and handling of the incision/insertion tools, and to assess the sensing quality of BIOMONITOR III
Primary Endpoint
- Adverse Events (procedure/device related)
- R-wave amplitude
Major Secondary Endpoints
- Insertion procedure of the BIOMONITOR III by using the incision and insertion tools
- Assessment of insertion procedure by using a questionnaire about handling and time record
Clinical Sites
- 10 sites in Australia
Sample Size
- 48 patients
Main Inclusion Criteria
Patients had to have one of the following indications for ICM:
- symptoms of palpitations, presyncope, or syncope suggestive of an underlying cardiac arrhythmia
- cryptogenic stroke
- high risk of developing a clinically important cardiac arrhythmia
- having undergone or awaiting catheter ablation of atrial fibrillation
Main Exclusion Criteria
- existing cardiac implantable electronic device
- participation in another interventional clinical investigation
- pregnancy or breast feeding
- life expectancy less than 6 months
Follow-Up
- 1 month
Reference no.
- NCT03850327
Principal Investigators
- Justin A. Mariani (The Alfred Hospital, Australia)
- Olivier van den Brink (The Alfred Hospital, Australia)