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

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

Study Overview

• Status: Completed
• Conditions: Insertable Cardiac Monitor
• Intervention / Treatment: Device: BioMonitor 2 Insertable Cardiac Monitor

• Study Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Flint, Michigan, United States
    • Saginaw, Michigan, United States
  • Missouri
    • Saint Louis, Missouri, United States
  • North Carolina
    • Greenville, North Carolina, United States
  • Ohio
    • Columbus, Ohio, United States
  • South Carolina
    • Greenville, South Carolina, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Insertion through 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	At insertion
Characterization of Insertion Procedure: Incision Size		At insertion
Characterization of Insertion Procedure: Procedure Duration		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.	Insertion, Wound Check (5 to 14 days post-insertion), 90-day (75 to 120 days post-insertion)

Collaborators and Investigators

• Sponsor: Biotronik, Inc.

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: April 27, 2016
• First Submitted That Met QC Criteria: April 27, 2016
• First Posted (ESTIMATE): April 29, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2018
• Last Update Submitted That Met QC Criteria: September 28, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: BioInsight

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO