BIO|CONCEPT.BIOMONITOR III

BIO|CONCEPT.BIOMONITOR III

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 1

BIOMONITOR III shows a high and stable R-wave amplitude

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 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)