BIO|CONCEPT.BIOMONITOR III

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 Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Syncope; Tachyarrhythmia
• Intervention / Treatment: Device: BIOMONITOR III

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIOMONITOR III	Device: BIOMONITOR III; Patients with ICM indication receive a third-generation implantable cardiac monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	(procedure / device related)	1 month
R-wave amplitude		1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the day of insertion of the BIOMONITOR III

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG
• Investigators: Principal Investigator: Olivier van den Brink, Dr., The Alfred Hospital, Melbourne, Australia

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2019
• Primary Completion (Actual): October 6, 2019
• Study Completion (Actual): October 6, 2019

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Implantable Cardiac Monitor
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Unconsciousness; Consciousness Disorders; Atrial Fibrillation; Tachycardia; Syncope
• Other Study ID Numbers: RD020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No