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

Completed

Conditions studied: Insertable Cardiac Monitor

In brief

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

Key facts

Study ID

NCT02756338

Run by

Biotronik, Inc.

People needed

77

Starts

2016-06-01

Expected to finish

2017-07-01

Last updated by the study team

2018-10-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Flint, Michigan, United States
• Study site — Saginaw, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Greenville, North Carolina, United States
• Study site — Columbus, Ohio, United States
• Study site — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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