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

B

Biotronik

Status

Completed

Conditions

Insertable Cardiac Monitor

Treatments

Device: BioMonitor 2 Insertable Cardiac Monitor

Study type

Observational

Funder types

Industry

Identifiers

NCT02756338
BioInsight

Details and patient eligibility

About

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

Enrollment

77 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Trial documents
1

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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