NCT02756338已完成不适用
BioMonitor 2 In-Office Setting Insertion Safety and Feasibility Evaluation With Device Functionality Assessment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 主要终点
- Number of Participants With Insertion Procedure-related Adverse Event That Requires Additional Invasive Intervention to Resolve
研究概览
简要总结
The purpose of this study is to evaluate the safety and feasibility of performing the BioMonitor 2 insertion procedure in an office setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of Participants With Insertion Procedure-related Adverse Event That Requires Additional Invasive Intervention to Resolve
时间窗: Insertion through 90 days
In order to be included in the primary objective analysis, insertion procedure-related adverse events must also include resolution by invasive action such as device removal, device replacement, surgical repositioning of the device, or another surgery preformed related to the device or primary insertion procedure.
次要结局
- Characterization of Device Functionality Post-insertion: R-wave Amplitudes(Insertion, Wound Check (5 to 14 days post-insertion), 90-day (75 to 120 days post-insertion))
- Characterization of Insertion Procedure: Device Orientation(At insertion)
- Characterization of Insertion Procedure: Incision Size(At insertion)
- Number of Participants With Insertion Procedure-related Adverse Event Not Included in Primary Objective(Insertion through 90 days)
- Characterization of Insertion Procedure: Procedure Duration(At insertion)
研究者
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