TachyarrhythmiaNCT02565238
BIO.MASTER.BioMonitor 2 Study
An observational study of Tachyarrhythmia and Atrial Fibrillation, run by Biotronik SE & Co. KG.
Trial summary
The objective of the study is to confirm safety and efficacy of the BioMonitor 2. The data is collected to support the regulatory approval of this product in countries outside the CE region. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Tachyarrhythmia, Atrial Fibrillation, Syncope
- What is being tested?
- BioMonitor 2
- Type of treatment
- Medical device
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Feb 2017
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient collective consists mainly of patients with indications of an insertable cardiac monitor or who are planned for loop recorded guided AF-therapy management. The investigator will select patients who are appropriate for particiation from his general patient population.
Who may be able to join
- Patients without history of atrial fibrillation and with an indication for BioMonitor 2 device or paients planned for loop recorded guided AF-therapy management, with either current known and documented paroxysmal atrial fibrillation or with current known and documented persistent atrial fibrillation indicated for an ablation or was ablated within the last four weeks.
- Patient is able to understand the nature of the study and provides written informed consent.
- Patient is able and willing to complete the planned follow-up visits at the investigational site.
- Patient accepts the Home Monitoring® concept.
- Age is ≥ 18 years.
Who cannot join
- Patients implanted with ICD or pacemaker.
- Patient who is pregnant and/or breast-feeding or who intends to become pregnant during the time of the study will be excluded.
- Life expectancy of less than 6 months.
- Participation in another interventional clinical investigation. Participation in a non-interventional study is permitted.
About this study
Official title: Master Study of the Insertable Cardiac Monitor BioMonitor 2.
The objective of the study is to confirm safety and efficacy of the BioMonitor 2. The data is collected to support the regulatory approval of this product in countries outside the CE region.
- Conditions
- Tachyarrhythmia, Atrial Fibrillation, Syncope
- Being tested
- BioMonitor 2
- Medical subject headings
- Tachycardia, Atrial Fibrillation, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioMonitor 2Device
Implantation of BioMonitor 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Device Effect (SADE)-free rate ≥ 90% related to BioMonitor 2
Measured: 3 month
Secondary outcomes (1)
R-Wave amplitude ≥ 0.3 mV
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TachyarrhythmiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Piorkowski, MD, Principal investigator, Heart Center Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565238
- Sponsor's protocol ID
- BA105
- Status last verified
- May 2017
- First submitted
- 30 Sep 2015
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Master Study of the Insertable Cardiac Monitor BioMonitor 2.
- ClinicalTrials.gov ID
- NCT02565238
- Acronym / sponsor ID
- BA105
- Conditions
- Tachyarrhythmia, Atrial Fibrillation, Syncope
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 1 Oct 2015 (estimated)
- 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 safety and efficacy of the BioMonitor 2. The data is collected to support the regulatory approval of this product in countries outside the CE region.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient collective consists mainly of patients with indications of an insertable cardiac monitor or who are planned for loop recorded guided AF-therapy management. The investigator will select patients who are appropriate for particiation from his general patient population.
Key inclusion criteria (5 listed)
- Patients without history of atrial fibrillation and with an indication for BioMonitor 2 device or paients planned for loop recorded guided AF-therapy management, with either current known and documented paroxysmal atrial fibrillation or with current known and documented persistent atrial fibrillation indicated for an ablation or was ablated within the last four weeks.
- Patient is able to understand the nature of the study and provides written informed consent.
- Patient is able and willing to complete the planned follow-up visits at the investigational site.
- Patient accepts the Home Monitoring® concept.
- Age is ≥ 18 years.
Key exclusion criteria (4 listed)
- Patients implanted with ICD or pacemaker.
- Patient who is pregnant and/or breast-feeding or who intends to become pregnant during the time of the study will be excluded.
- Life expectancy of less than 6 months.
- Participation in another interventional clinical investigation. Participation in a non-interventional study is permitted.
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 2Implantation of BioMonitor 2 | Device | – |
Primary outcome
Serious Adverse Device Effect (SADE)-free rate ≥ 90% related to BioMonitor 2
Time frame: 3 month
1 secondary outcome
R-Wave amplitude ≥ 0.3 mV
Time frame: 1 week
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 8 May 2017.
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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.
Christopher Piorkowski, MD principal investigator
Heart Center Dresden, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Tachyarrhythmia and Atrial Fibrillation, run by Biotronik SE & Co. KG.
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 5 inclusion and 4 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 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Serious Adverse Device Effect (SADE)-free rate ≥ 90% related to BioMonitor 2 (time frame: 3 month). 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 8 May 2017.