Micra Accelerometer Sensor Study 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 4
- 主要终点
- Waveform and Components of Accelerometer Signal
研究概览
简要总结
The purpose of the MASS2 is to characterize accelerometer signals of Micra implantable device during different postures and activities and to understand the source of the sensed motion, in order to test feasibility for future enhancements in device functionalities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Subject is ≥ 18 years old
- •Subject is implanted with a Micra device
- •Subject or witness (if applicable as per local regulation) is able and willing to provide Informed Consent
排除标准
- •Subject is in atrial fibrillation
- •Subject is not able to perform study requirements
研究组 & 干预措施
Investigational Software
Investigational Software loaded on Micra device
干预措施: Investigational Software loaded on Micra device (Device)
结局指标
主要结局
Waveform and Components of Accelerometer Signal
时间窗: For approximately two hours after software download
Accelerometer signal was measured using the 3 axis Micra accelerometer (Vector 1 was labelled as V1, Vector 2 as V2, Vector 3 as V3). Components of the accelerometer signals (unit (g) represent acceleration)were identified and labelled as A1 (acceleration associated with ventricular systole), A2 (ventricular diastole), A3 (early passive filling), and A4 (active filling). The A4 signal is associated with atrial contraction and active filling.
次要结局
未报告次要终点