Atrial FibrillationNCT03850327
BIO|CONCEPT.BIOMONITOR III
A study testing BIOMONITOR III in people with Atrial Fibrillation and Syncope, run by Biotronik SE & Co. KG at 7 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Atrial Fibrillation, Syncope, Tachyarrhythmia
- What is being tested?
- BIOMONITOR III
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 7 sitesAustralia
- Study dates
- 8 Mar 2019to 6 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Australia7 sites
HeartCare Partners - Wesley Testing
Auchenflower, Queensland, 4066
HeartCare Victoria - Doncaster
Balwyn, Victoria, 3103
Bundaberg Cardiology
Bundaberg, Queensland, 4670
The Canberra Hospital
Canberra, 2605
The Alfred Hospital
Melbourne, 3004
Mount Hospital
Perth, Western Australia, 6000
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
About this study
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.
- Conditions
- Atrial Fibrillation, Syncope, Tachyarrhythmia
- Being tested
- BIOMONITOR III
- Keywords
- Implantable Cardiac Monitor
- Medical subject headings
- Atrial Fibrillation, Syncope, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOMONITOR IIIDevice
Patients with ICM indication receive a third-generation implantable cardiac monitor
| Study group | Role | What they receive |
|---|---|---|
| BIOMONITOR III | Experimental | Not described Receives: Device: BIOMONITOR III |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
(procedure / device related)
Measured: 1 month
R-wave amplitude
Measured: 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.
Measured: At the day of insertion of the BIOMONITOR III
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start8 Mar 2019
- Primary completion6 Oct 2019
- Study completion6 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olivier van den Brink, Dr., Principal investigator, The Alfred Hospital, Melbourne, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850327
- Sponsor's protocol ID
- RD020
- Status last verified
- Dec 2018
- First submitted
- 11 Feb 2019
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIO|CONCEPT.BIOMONITOR III
- ClinicalTrials.gov ID
- NCT03850327
- Acronym / sponsor ID
- RD020
- Conditions
- Atrial Fibrillation, Syncope, Tachyarrhythmia
- Keywords
- Implantable Cardiac Monitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 6 Oct 2019 (actual)
- Study completion
- 6 Oct 2019 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIOMONITOR III | Experimental | Device: BIOMONITOR III |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIOMONITOR IIIPatients with ICM indication receive a third-generation implantable cardiac monitor | Device | BIOMONITOR III |
Primary outcome
Adverse Events
Time frame: 1 month
(procedure / device related)
R-wave amplitude
Time frame: 1 month
1 secondary outcome
Insertion procedure of the BIOMONITOR III by using the incision and insertion tools
Time frame: At the day of insertion of the BIOMONITOR III
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier van den Brink, Dr. principal investigator
The Alfred Hospital, Melbourne, Australia
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIOMONITOR III in people with Atrial Fibrillation and Syncope, run by Biotronik SE & Co. KG at 7 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.