Clinical trial NCT02756338: BioMonitor 2 In-Office Setting Insertion Safety and Feasibility Evaluation With Device Functionality Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insertable Cardiac Monitor
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-29
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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 outcomes:
measure: Number of Participants With Insertion Procedure-related Adverse Event That Requires Additional Invasive Intervention to Resolve
timeFrame: Insertion through 90 days
Secondary outcomes:
measure: Number of Participants With Insertion Procedure-related Adverse Event Not Included in Primary Objective
timeFrame: Insertion through 90 days
measure: Characterization of Insertion Procedure: Device Orientation
timeFrame: At insertion
measure: Characterization of Insertion Procedure: Incision Size
timeFrame: At insertion
measure: Characterization of Insertion Procedure: Procedure Duration
timeFrame: At insertion
measure: Characterization of Device Functionality Post-insertion: R-wave Amplitudes
timeFrame: Insertion, Wound Check (5 to 14 days post-insertion), 90-day (75 to 120 days post-insertion)
Other outcomes:
Locations:
city: Flint
country: United States
state: Michigan
city: Saginaw
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: Greenville
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Greenville
country: United States
state: South Carolina
Study officials:
References:
citation: 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.