NCT02565238已完成不适用
Master Study of the Insertable Cardiac Monitor BioMonitor 2.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 主要终点
- Serious Adverse Device Effect (SADE)-free rate ≥ 90% related to BioMonitor 2
研究概览
简要总结
The objective of the study is to confirm safety and efficacy of the BioMonitor 2. The data is collected to support the regulatory approval of this product in countries outside the CE region.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients without history of atrial fibrillation and with an indication for BioMonitor 2 device or paients planned for loop recorded guided AF-therapy management, with either current known and documented paroxysmal atrial fibrillation or with current known and documented persistent atrial fibrillation indicated for an ablation or was ablated within the last four weeks.
- •Patient is able to understand the nature of the study and provides written informed consent.
- •Patient is able and willing to complete the planned follow-up visits at the investigational site.
- •Patient accepts the Home Monitoring® concept.
- •Age is ≥ 18 years.
排除标准
- •Patients implanted with ICD or pacemaker.
- •Patient who is pregnant and/or breast-feeding or who intends to become pregnant during the time of the study will be excluded.
- •Life expectancy of less than 6 months.
- •Participation in another interventional clinical investigation. Participation in a non-interventional study is permitted.
结局指标
主要结局
Serious Adverse Device Effect (SADE)-free rate ≥ 90% related to BioMonitor 2
时间窗: 3 month
次要结局
- R-Wave amplitude ≥ 0.3 mV(1 week)
研究者
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