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(NCT02756338)

The purpose of this study is to evaluate the safety and feasibility of performing the BioMonitor 2 insertion procedure in an office setting.
  • Device: BioMonitor 2 Insertable Cardiac Monitor
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    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

    6 locations

    United States (6)
    • Not specified
      Flint, Michigan, United States
    • Not specified
      Saginaw, Michigan, United States
    • Not specified
      Saint Louis, Missouri, United States
    • Not specified
      Greenville, North Carolina, United States
    • Not specified
      Columbus, Ohio, United States
    • Not specified
      Greenville, South Carolina, United States
    Status:
    completed
    Type:
    Observational
    Phase:
    -
    Start:
    31 May, 2016
    Updated:
    14 August, 2017
    Participants:
    77
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