N/A
Completed N=77
BioMonitor 2 In-Office Setting Insertion Safety and Feasibility Evaluation With Device Functionality Assessment
Insertable Cardiac Monitor
Source: ClinicalTrials.gov NCT02756338 ↗
Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcomePrimary: Number of Participants With Insertion Procedure-related Adverse Event That Requires Additional Invasive Intervention to Resolve — 0 participants with a Primary Objective AE
Summary
The purpose of this study is to evaluate the safety and feasibility of performing the BioMonitor 2 insertion procedure in an office setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Insertion Procedure-related Adverse Event That Requires Additional Invasive Intervention to Resolve |
— | — |
| SECONDARY Number of Participants With Insertion Procedure-related Adverse Event Not Included in Primary Objective |
2 | — |
| SECONDARY Characterization of Insertion Procedure: Device Orientation |
35; 38; 1; 3 | — |
| SECONDARY Characterization of Insertion Procedure: Incision Size |
14.9 | — |
| SECONDARY Characterization of Insertion Procedure: Procedure Duration |
8.4 | — |
| SECONDARY Characterization of Device Functionality Post-insertion: R-wave Amplitudes |
0.77; 0.69; 0.67; 0.68 | — |
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
Data sourced from ClinicalTrials.gov (NCT02756338). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.