The purpose of this study is to evaluate the safety and feasibility of performing the BioMonitor 2 insertion procedure in an office setting.
Study Type
OBSERVATIONAL
Enrollment
77
Unnamed facility
Flint, Michigan, United States
Unnamed facility
Saginaw, Michigan, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Greenville, North Carolina, United States
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.
Time frame: Insertion through 90 days
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
Time frame: 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.
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
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Columbus, Ohio, United States
Unnamed facility
Greenville, South Carolina, United States