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

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