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

Completed

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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
Characterization of Insertion Procedure: Incision Size	At insertion
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
Characterization of Insertion Procedure: Procedure Duration	At insertion