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

• Sponsor: Biotronik, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02756338
• Collaborator: (none)
• Enrollment: 77
• Locations: 6
• Duration (Months): 13
• Patients Per Site: 12.8
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Insertable Cardiac Monitor	Device: BioMonitor 2 Insertable Cardiac Monitor

Study Design

• Study Type: Observational
• Actual Enrollment: 77 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Jul 1, 2017
• Actual Study Completion Date: Jul 1, 2017

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Insertion Procedure-related Adverse Event That Requires Additional Invasive Intervention to Resolve [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.

Secondary Outcome Measures

1. Number of Participants With Insertion Procedure-related Adverse Event Not Included in Primary Objective [Insertion through 90 days]

   All insertion procedure-related adverse events not included in the Primary Objective

2. Characterization of Insertion Procedure: Device Orientation [At insertion]

   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.

3. Characterization of Insertion Procedure: Incision Size [At insertion]

4. Characterization of Insertion Procedure: Procedure Duration [At insertion]

5. Characterization of Device Functionality Post-insertion: R-wave Amplitudes [Insertion, Wound Check (5 to 14 days post-insertion), 90-day (75 to 120 days post-insertion)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Flint	Michigan	United States
2		Saginaw	Michigan	United States
3		Saint Louis	Missouri	United States
4		Greenville	North Carolina	United States
5		Columbus	Ohio	United States
6		Greenville	South Carolina	United States

Sponsors and Collaborators

• Biotronik, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 11, 2016

More Information

Publications

None provided.

• Responsible Party: Biotronik, Inc.
• ClinicalTrials.gov Identifier: NCT02756338
• Other Study ID Numbers: BioInsight
• First Posted: Apr 29, 2016
• Last Update Posted: Oct 26, 2018
• Last Verified: Sep 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

Participant Flow

Arm/Group Title	BioMonitor 2 In-Office Setting Insertion Group
Arm/Group Description	Post-market Study: Collecting safety and feasibility of performing office based insertion of a market-released insertable cardiac monitor.
Period Title: Overall Study
STARTED	77
COMPLETED	72
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	BioMonitor 2 In-Office Setting Insertion Group
Arm/Group Description	Post-market Study: Collecting safety and feasibility of performing office based insertion of a market-released insertable cardiac monitor.
Overall Participants	77
Age, Customized (years) [Mean (Standard Deviation) ]
Age at Enrollment	62.1 (15.38)
Sex: Female, Male (Count of Participants)
Female	36 46.8%
Male	41 53.2%
Race/Ethnicity, Customized (Count of Participants)
White	71 92.2%
Black or African American	5 6.5%
Race Not Specified	1 1.3%
Not Hispanic or Latino Ethnicity	76 98.7%
Ethnicity Not Specified	1 1.3%
Height (inches) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [inches]	67.8 (4.82)
Weight (pounds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pounds]	205.6 (47.93)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Insertion Procedure-related Adverse Event That Requires Additional Invasive Intervention to Resolve
Description	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.
Time Frame	Insertion through 90 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	BioMonitor 2 In-Office Setting Insertion Group
Arm/Group Description	Post-market Study: Collecting safety and feasibility of performing office based insertion of a market-released insertable cardiac monitor.
Measure Participants	72
Number [participants with a Primary Objective AE]	0 0%

2. Secondary Outcome

Title	Number of Participants With Insertion Procedure-related Adverse Event Not Included in Primary Objective
Description	All insertion procedure-related adverse events not included in the Primary Objective
Time Frame	Insertion through 90 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	BioMonitor 2 In-Office Setting Insertion Group
Arm/Group Description	Post-market Study: Collecting safety and feasibility of performing office based insertion of a market-released insertable cardiac monitor.
Measure Participants	73
Count of Participants [Participants]	2 2.6%

3. Secondary Outcome

Title	Characterization of Insertion Procedure: Device Orientation
Description	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.
Time Frame	At insertion

Outcome Measure Data

Analysis Population Description

All subjects who underwent insertion

Arm/Group Title	BioMonitor 2 In-Office Setting Insertion Group
Arm/Group Description	Post-market Study: Collecting safety and feasibility of performing office based insertion of a market-released insertable cardiac monitor.
Measure Participants	77
Position A	35 45.5%
Position B	38 49.4%
Position C	1 1.3%
Other	3 3.9%

4. Secondary Outcome

Title	Characterization of Insertion Procedure: Incision Size
Time Frame	At insertion

Outcome Measure Data

Analysis Population Description

Number of participants analyzed included all subjects with a reported incision size. Incision size was not collected or reported for 3 participants.

Arm/Group Title	BioMonitor 2 In-Office Setting Insertion Group
Arm/Group Description	Post-market Study: Collecting safety and feasibility of performing office based insertion of a market-released insertable cardiac monitor.
Measure Participants	74
Mean (Standard Deviation) [millimeters]	14.9 (3.74)

5. Secondary Outcome

Title	Characterization of Insertion Procedure: Procedure Duration
Time Frame	At insertion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BioMonitor 2 In-Office Setting Insertion Group
Arm/Group Description	Post-market Study: Collecting safety and feasibility of performing office based insertion of a market-released insertable cardiac monitor.
Measure Participants	77
Mean (Standard Deviation) [minutes]	8.4 (3.69)

6. Secondary Outcome

Title	Characterization of Device Functionality Post-insertion: R-wave Amplitudes
Description	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.
Time Frame	Insertion, Wound Check (5 to 14 days post-insertion), 90-day (75 to 120 days post-insertion)

Outcome Measure Data

Analysis Population Description

Five subjects did not complete their 90-day visits as reported in Participant Flow and therefore data was not collected for those visits. Only one subject did not transmit to Home Monitoring due to poor reception and therefore there was no data for this patient in Home Monitoring.

Arm/Group Title	BioMonitor 2 In-Office Setting Insertion Group
Arm/Group Description	Post-market Study: Collecting safety and feasibility of performing office based insertion of a market-released insertable cardiac monitor.
Measure Participants	77
Insertion Procedure Visit	0.77 (0.5)
Wound Check Visit	0.69 (0.4)
90-day Follow-up Visit	0.67 (0.3)
Home Monitoring 90-day Average	0.68 (0.34)

Adverse Events

Time Frame	Insertion through 90 days
Arm/Group Title	BioMonitor 2 In-Office Setting Insertion Group
Arm/Group Description	Post-market Study: Collecting safety and feasibility of performing office based insertion of a market-released insertable cardiac monitor.
All Cause Mortality
	BioMonitor 2 In-Office Setting Insertion Group
	Affected / at Risk (%)	# Events
Total	0/77 (0%)
Serious Adverse Events
	BioMonitor 2 In-Office Setting Insertion Group
	Affected / at Risk (%)	# Events
Total	0/77 (0%)
Other (Not Including Serious) Adverse Events
	BioMonitor 2 In-Office Setting Insertion Group
	Affected / at Risk (%)	# Events
Total	2/77 (2.6%)
Surgical and medical procedures
Secondary Infection	1/77 (1.3%)	1
Surrounding Tissue Damage	1/77 (1.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Principal Investigators agree to submit copies of any manuscript proposed for publication to Sponsor for review at least 30 days in advance of submission for publication or presentation. Sponsor may extend such review period another 90 days to file patent applications to take other steps to protect its intellectual property interests, or to remove from the paper or presentation any language that is detrimental to Sponsor's intellectual property interests.