The LIVMOR Data Collection Study for the Development and Validation of L-1000AF System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LIVMOR, Inc.
- 入组人数
- 271
- 试验地点
- 4
- 主要终点
- Concurrent Atrial Fibrillation
研究概览
简要总结
The LIVMOR Data Collection Study is a multicenter, IDE Exempt Study to generate a library of device-specific signals collected noninvasively. The study was not designed to evaluate specific hypothesis or endpoint, rather it was intended for data collection purposes to generate a library of raw clinical data that were retrospectively used for the development and subsequently the validation of the L-1000AF System. The L-1000AF System is a wrist worn system intended to provide continuous remote monitoring of atrial fibrillation (AF) episodes. The system is intended for use under the care of a physician and is not intended for the diagnosis of AF.
详细描述
LIVMOR is developing a series of wearable medical device systems intended to promote general wellness and help subjects and physicians manage various diseases that can benefit from increased visibility of physical activity, sleep, weight, blood pressure, stress/recovery levels and cardiac rhythms.
Data from human subjects is necessary to develop and validate LIVMOR devices. LIVMOR completed a multicenter, IDE Exempt Study to generate a library of device-specific signals collected non-invasively using components of the LIVMOR system and simultaneously acquired with ECG Holter data using a commercially available Holter monitor. Data from the analysis of the Holter monitor was adjudicated by physicians skilled in the analysis and interpretation of ECGs compared to the analysis from the LIVMOR AF Detection Algorithm to establish the sensitivity and specificity of the algorithm for detection of AF in comparison to ground truth.
The study was not designed to evaluate specific hypotheses or endpoint, rather it was intended for data collection purposes to generate a library of raw clinical data that were retrospectively used for the development and subsequently the validation of the L-1000AF System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- 是
入选标准
- •Willing, able and sufficiently motivated to attend all study visits and participate in all study activities; and
- •Physically and mentally capable of providing informed consent and are at least 18 years of age or of legal age to provide consent as required by local and national requirements.
排除标准
- •Has any unstable or significant medical condition that is likely to interfere with study procedures or subjects medical care;
- •Has any implantable electronic medical device;
- •Has significant hearing, visual or cognitive impairment as determined by the Investigator; and
- •Participating in any other clinical study without written consent from the Sponsor
结局指标
主要结局
Concurrent Atrial Fibrillation
时间窗: 10 minutes
Simultaneous ECG monitoring indicating Atrial Fibrillation rhythm.
Detection of Atrial Fibrillation
时间窗: 10 minutes
A decision of Atrial Fibrillation detection in at least one 192-beat window.
次要结局
未报告次要终点