NCT04198220已完成不适用
BIO|STREAM.ICM Obesity, Submodule of the BIO|STREAM.ICM Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- R-wave amplitude
研究概览
简要总结
The aim of the submodule study is to assess whether a high BMI may influence the sensing performance and the sECG quality of the BIOMONITOR.
详细描述
This submodule of the BIO|STREAM.ICM registry specifically investigates the performance of the BIOMONITOR in a subset of obese patients with a BMI >30 kg/m2 in order to exclude any concerns regarding impaired ICM sensing performance. These concerns are founded in the increased distance between heart and device electrodes due to fat layers that may attenuate signal detection and therefore sensing performances of the ICM.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patient is already enrolled in the BIO|STREAM.ICM registry
- •Patient BMI > 30
排除标准
- •Patient clinically indicated for or already implanted with another cardiac active device
结局指标
主要结局
R-wave amplitude
时间窗: 3 month
R-wave amplitude at 3-month Home Monitoring observation in patients with a BMI \> 30
次要结局
- Amount of 'noise burden'(3 month)
- P-wave visibility(1 month and 3 month)
研究者
研究点 (1)
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