NCT03850327已完成不适用
BIO|CONCEPT.BIOMONITOR III
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 14
- 主要终点
- Adverse Events
研究概览
简要总结
The objective of the study is to confirm the safety and efficacy of the BIOMONITOR III system. Furthermore, the insertion procedure, the use and handling of the incision and insertion tools and the sensing quality of the BIOMONITOR III will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is at high risk of developing a clinically important cardiac arrhythmia; or Patient is undergoing investigation for symptoms such as palpitations, pre-syncope or syncope, that are suggestive of an underlying cardiac arrhythmia; or Patient is undergoing investigation for the detection of atrial fibrillation following cryptogenic stroke; or Patient is planned for AF ablative procedure or has already undergone an AF ablative procedure.
- •Patient is able to understand the nature of study and has provided written informed consent.
- •Patient is willing and able to perform all follow up visits at the study site.
- •Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.
排除标准
- •Patients implanted with ICD or pacemaker.
- •Patient is pregnant or breast feeding.
- •Patient is less than 18 years old.
- •Patient is participating in another interventional clinical investigation
- •Patient´s life-expectancy is less than 6 months.
结局指标
主要结局
Adverse Events
时间窗: 1 month
(procedure / device related)
R-wave amplitude
时间窗: 1 month
次要结局
- Insertion procedure of the BIOMONITOR III by using the incision and insertion tools(At the day of insertion of the BIOMONITOR III)
研究者
研究点 (14)
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