Insertable Cardiac MonitorBioInsightNCT02756338

BioMonitor 2 In-Office Setting Insertion Safety and Feasibility Evaluation With Device Functionality Assessment

An observational study of Insertable Cardiac Monitor, run by Biotronik, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the safety and feasibility of performing the BioMonitor 2 insertion procedure in an office setting. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Insertable Cardiac Monitor
What is being tested?: BioMonitor 2 Insertable Cardiac Monitor
Type of treatment: Medical device
How many people: 77 participants
Where: 6 sitesUnited States
Study dates: Jun 2016to Jul 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Subjects indicated for continuous arrhythmia monitoring who are willing to undergo the insertion procedure in an office setting

Who may be able to join

Indicated for continuous monitoring with an insertable cardiac monitor
Willing to be implanted in an office setting with only local anesthetic available
Able to understand the nature of the study and provide informed consent
Able and willing to complete all routine follow-up visits at the study site for the expected 90-day follow-up
Able and willing to use a CardioMessenger® capable of communicating with the BioMonitor 2
Age greater than or equal to 18 years

Show all 9Show fewer

At the time of insertion, the following pre-procedure criteria must be met for the subject to undergo insertion:
Most recent INR value (within 7 days) is less than 3.5 if currently taking warfarin
Absence of infection with no history of infection within the last 30 days

Who cannot join

Compromised immune system or at high risk of developing an infection
Abnormal thoracic anatomy or scar tissue at the implant site that may adversely impact the insertion procedure
Enrolled in any investigational cardiac device trial
Currently indicated for or implanted with a pacemaker, ICD device, or hemodynamic monitoring system
Currently implanted with an ICM or ILR
Life expectancy less than 6 months
Patients reporting pregnancy at the time of enrollment

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Study site
Columbus, Ohio
Study site
Flint, Michigan
Study site
Greenville, North Carolina
Study site
Greenville, South Carolina
Study site
Saginaw, Michigan
Study site
St Louis, Missouri

Other trials in United States

About this study

The purpose of this study is to evaluate the safety and feasibility of performing the BioMonitor 2 insertion procedure in an office setting.

Conditions: Insertable Cardiac Monitor
Being tested: BioMonitor 2 Insertable Cardiac Monitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BioMonitor 2 Insertable Cardiac MonitorDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Insertion Procedure-related Adverse Event That Requires Additional Invasive Intervention to Resolve
In order to be included in the primary objective analysis, insertion procedure-related adverse events must also include resolution by invasive action such as device removal, device replacement, surgical repositioning of the device, or another surgery preformed related to the device or primary insertion procedure.
Measured: Insertion through 90 days

Secondary outcomes (5)

Number of Participants With Insertion Procedure-related Adverse Event Not Included in Primary Objective
All insertion procedure-related adverse events not included in the Primary Objective
Measured: Insertion through 90 days
Characterization of Insertion Procedure: Device Orientation
Position A includes orientations at 45 degrees relative to the sternum over the fourth intercostal space, position B includes orientations parallel to the sternum over the fourth intercostal space, and position C includes orientations perpendicular to the sternum and sub-mammary.
Measured: At insertion
Characterization of Insertion Procedure: Incision Size
Measured: At insertion
Characterization of Insertion Procedure: Procedure Duration
Measured: At insertion
Characterization of Device Functionality Post-insertion: R-wave Amplitudes
This includes average R-wave amplitudes collected at insertion, wound check, and 90-day study visits. Long-term trends available through Home Monitoring from insertion through the 90-day study period was also collected and presented as a separate average.
Measured: Insertion, Wound Check (5 to 14 days post-insertion), 90-day (75 to 120 days post-insertion)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2016Jul 2017

First posted29 Apr 2016 (estimated)
Study startJun 2016
Primary completionJul 2017
Study completionJul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Insertable Cardiac MonitorStudies 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: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02756338
Sponsor's protocol ID: BioInsight
Acronym: BioInsight
Status last verified: Sep 2018
First submitted: 27 Apr 2016
Last updated: 26 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Awad K, Weiss R, Yunus A, Bittrick JM, Nekkanti R, Houmsse M, Okabe T, Adamson T, Miller C, Alawwa AK. BioMonitor 2 in-office setting insertion safety and feasibility evaluation with device functionality assessment: results from the prospective cohort BioInsight study. BMC Cardiovasc Disord. 2020 Apr 15;20(1):171. doi: 10.1186/s12872-020-01439-8.
PubMed 32293279

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure Patients
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Insertable Cardiac Monitor-Guided Early Intervention to Reduce Atrial Fibrillation Burden Following Catheter Ablation
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Active, not recruiting
Future Cardia™ Insertable Cardiac Monitor in Subjects With Paroxysmal Atrial Fibrillation (First-in-Human Study)
Arrhythmias, Cardiac, Atrial Fibrillation

All Insertable Cardiac Monitor trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BioMonitor 2 In-Office Setting Insertion Safety and Feasibility Evaluation With Device Functionality Assessment
ClinicalTrials.gov ID: NCT02756338
Acronym / sponsor ID: BioInsight / BioInsight
Conditions: Insertable Cardiac Monitor
Study type: Observational
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: Biotronik, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2016
Primary completion: Jul 2017 (actual)
Study completion: Jul 2017 (actual)
First posted: 29 Apr 2016 (estimated)
Results: Posted 10 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the safety and feasibility of performing the BioMonitor 2 insertion procedure in an office setting.

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects indicated for continuous arrhythmia monitoring who are willing to undergo the insertion procedure in an office setting

Key inclusion criteria (9 listed)

Indicated for continuous monitoring with an insertable cardiac monitor
Willing to be implanted in an office setting with only local anesthetic available
Able to understand the nature of the study and provide informed consent
Able and willing to complete all routine follow-up visits at the study site for the expected 90-day follow-up
Able and willing to use a CardioMessenger® capable of communicating with the BioMonitor 2

Key exclusion criteria (7 listed)

Compromised immune system or at high risk of developing an infection
Abnormal thoracic anatomy or scar tissue at the implant site that may adversely impact the insertion procedure
Enrolled in any investigational cardiac device trial
Currently indicated for or implanted with a pacemaker, ICD device, or hemodynamic monitoring system
Currently implanted with an ICM or ILR

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 2 Insertable Cardiac Monitor	Device	–

Primary outcome

Number of Participants With Insertion Procedure-related Adverse Event That Requires Additional Invasive Intervention to Resolve
Time frame: Insertion through 90 days
In order to be included in the primary objective analysis, insertion procedure-related adverse events must also include resolution by invasive action such as device removal, device replacement, surgical repositioning of the device, or another surgery preformed related to the device or primary insertion procedure.

5 secondary outcomes

Number of Participants With Insertion Procedure-related Adverse Event Not Included in Primary Objective
Time frame: Insertion through 90 days
Characterization of Insertion Procedure: Device Orientation
Time frame: At insertion
Characterization of Insertion Procedure: Incision Size
Time frame: At insertion
Characterization of Insertion Procedure: Procedure Duration
Time frame: At insertion
Characterization of Device Functionality Post-insertion: R-wave Amplitudes
Time frame: Insertion, Wound Check (5 to 14 days post-insertion), 90-day (75 to 120 days post-insertion)

Results and safety

Results posted to the registry on 10 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BioMonitor 2 In-Office Setting Insertion Group	77	72

Primary outcome: Number of Participants With Insertion Procedure-related Adverse Event That Requires Additional Invasive Intervention to Resolve

Time frame: Insertion through 90 days. Number. Unit: participants with a Primary Objective AE

Measure	BioMonitor 2 In-Office Setting Insertion Group n = 72
Value	0

Population analysed: The evaluable subject population is the sum of total unique subjects who completed the 90-day follow-up and/or who experienced a primary objective adverse event.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Insertion through 90 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BioMonitor 2 In-Office Setting Insertion Group	0 of 77 (0%)	2 of 77 (2.6%)	0 of 77

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32293279Awad K, Weiss R, Yunus A, Bittrick JM, Nekkanti R, Houmsse M, Okabe T, Adamson T, Miller C, Alawwa AK. BioMonitor 2 in-office setting insertion safety and feasibility evaluation with device functionality assessment: results from the prospective cohort BioInsight study. BMC Cardiovasc Disord. 2020 Apr 15;20(1):171. doi: 10.1186/s12872-020-01439-8.
Individual participant dataSharing planned: No

Related trials for Insertable Cardiac Monitor

Active, not recruiting
Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation
Persistent Atrial Fibrillation
Active, not recruiting
Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure Patients
Atrial Fibrillation, Heart Failure
Active, not recruiting
Insertable Cardiac Monitor-Guided Early Intervention to Reduce Atrial Fibrillation Burden Following Catheter Ablation
Atrial Fibrillation, Cardiovascular Diseases
Active, not recruiting
Future Cardia™ Insertable Cardiac Monitor in Subjects With Paroxysmal Atrial Fibrillation (First-in-Human Study)
Arrhythmias, Cardiac, Atrial Fibrillation

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.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Insertable Cardiac Monitor, run by Biotronik, Inc. at 6 sites in United States.

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 9 inclusion and 7 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 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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?

Yes. Results are posted in the registry (first posted 10 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Insertion Procedure-related Adverse Event That Requires Additional Invasive Intervention to Resolve (time frame: Insertion through 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02756338, which also lists 1 linked publication.

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 26 Oct 2018.