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CompletedNCT03850327Updated May 27, 2021

BIO|CONCEPT.BIOMONITOR III

An interventional study of BIOMONITOR III in Atrial Fibrillation, Syncope and Tachyarrhythmia, sponsored by Biotronik SE & Co. KG. Completed at 7 sites in Australia. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-05-27.

Sponsored by Biotronik SE & Co. KG · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Atrial Fibrillation
  • Syncope
  • Tachyarrhythmia

Keywords

  • Implantable Cardiac Monitor
03

In context

Syncope

226 studies on the registry are indexed under Syncope; 45 are open to participants now.

This study's enrollment of 48 is below the median of 79 across 126 interventional studies indexed under Syncope.

Browse Syncope studies →

Lead sponsor

Biotronik SE & Co. KG is the lead sponsor of 83 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient is at high risk of developing a clinically important cardiac arrhythmia; or Patient is undergoing investigation for symptoms such as palpitations, pre-syncope or syncope, that are suggestive of an underlying cardiac arrhythmia; or Patient is undergoing investigation for the detection of atrial fibrillation following cryptogenic stroke; or Patient is planned for AF ablative procedure or has already undergone an AF ablative procedure.
  • Patient is able to understand the nature of study and has provided written informed consent.
  • Patient is willing and able to perform all follow up visits at the study site.
  • Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.

Exclusion criteria

Exclusion Criteria:

  • Patients implanted with ICD or pacemaker.
  • Patient is pregnant or breast feeding.
  • Patient is less than 18 years old.
  • Patient is participating in another interventional clinical investigation
  • Patient´s life-expectancy is less than 6 months.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    BIOMONITOR III

    Device: BIOMONITOR III

Interventions

  • DeviceBIOMONITOR III

    Patients with ICM indication receive a third-generation implantable cardiac monitor

06

What researchers measure

Primary outcomes

  1. Adverse Events

    (procedure / device related)

    Time frame: 1 month

  2. R-wave amplitude

    Time frame: 1 month

Secondary outcomes

  1. 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

07

Study locations

7 sites
  • HeartCare Partners - Wesley Testing
    Auchenflower, Queensland 4066, Australia
  • Bundaberg Cardiology
    Bundaberg, Queensland 4670, Australia
  • Princess Alexandra Hospital
    Woolloongabba, Queensland 4102, Australia
  • HeartCare Victoria - Doncaster
    Balwyn, Victoria 3103, Australia
  • Mount Hospital
    Perth, Western Australia 6000, Australia
  • The Canberra Hospital
    Canberra, 2605, Australia
  • The Alfred Hospital
    Melbourne, 3004, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03850327
Lead sponsor
Biotronik SE & Co. KG
Responsible party
Sponsor
First posted
Feb 21, 2019
Start date
Mar 8, 2019
Primary completion
Oct 6, 2019
Completion
Oct 6, 2019
Last update
May 27, 2021

Study contacts

Olivier van den Brink, Dr.
principal investigator · The Alfred Hospital, Melbourne, Australia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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