BIO|CONCEPT.BIOMONITOR III
1 other identifier
interventional
48
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable atrial-fibrillation
Started Mar 2019
Shorter than P25 for not_applicable atrial-fibrillation
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2019
CompletedFirst Posted
Study publicly available on registry
February 21, 2019
CompletedStudy Start
First participant enrolled
March 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2019
CompletedMay 27, 2021
December 1, 2018
7 months
February 11, 2019
May 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adverse Events
(procedure / device related)
1 month
R-wave amplitude
1 month
Secondary Outcomes (1)
Insertion procedure of the BIOMONITOR III by using the incision and insertion tools
At the day of insertion of the BIOMONITOR III
Study Arms (1)
BIOMONITOR III
EXPERIMENTALInterventions
Patients with ICM indication receive a third-generation implantable cardiac monitor
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier van den Brink, Dr.
The Alfred Hospital, Melbourne, Australia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2019
First Posted
February 21, 2019
Study Start
March 8, 2019
Primary Completion
October 6, 2019
Study Completion
October 6, 2019
Last Updated
May 27, 2021
Record last verified: 2018-12