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

Insertable Cardiac Monitor Clinical Trial

— BioInsight  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02756338
• Other study ID #: BioInsight
• Status: Completed
• Start date: June 2016
• Est. completion date: July 2017

Study information

• Verified date: September 2018
• Source: Biotronik, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Insertable Cardiac Monitor

Intervention

Device:
• BioMonitor 2 Insertable Cardiac Monitor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Characterization of Insertion Procedure: Incision Size		At insertion
Secondary	Characterization of Insertion Procedure: Procedure Duration		At insertion
Secondary	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)