Evaluation of Blood Pressure Monitor With AFib Screening Feature
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 574
- 试验地点
- 10
- 主要终点
- Sensitivity
研究概览
简要总结
This study aims to evaluate the safety and effectiveness of the Omron blood pressure (BP) monitor with AFib screening feature. The primary outcome is to validate if the Omron BP-monitor with AFib screening feature meets acceptance criteria in sensitivity and specificity. The acceptance criteria of the sensitivity and specificity should be statistically non-inferior to those of primary predicate device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects are eligible to participate in the study if they meet all of the following criteria. AFib participants must meet criteria 1-
- •non-AFib participants must meet criteria 1-3 and 6-
- •Age ≥ 22 years old
- •Arm size within 22 cm to 42 cm in circumference
- •Participants who have an adequate understanding about the study and have given informed written consent before participation
- •Participants who were diagnosed with AFib and have regularly seen a cardiovascular specialist
- •Participants who have atrial fibrillation symptoms on ECG at the time of data collection
- •Participants who have never been diagnosed with atrial fibrillation
- •Participants who do not have AFib symptoms on ECG at data collection time
排除标准
- •Participants will be excluded from the study if they meet any of the following criteria.
- •Subjects who have difficulty in ECG or blood pressure measurement due to skin rashes or wounds on the chest or arm
- •Women who are pregnant at the time of study participation.
- •Subjects who have had a mastectomy.
- •Subjects with pacemakers and/or defibrillators.
- •Subjects who have difficulty in measuring blood pressure or ECG measurements in the sitting position.
- •Subjects who are hospitalized (in-patients)
- •Subjects whose pulse rate is less than 40 beats/minute or more than 180 beats/minute.
- •Subjects who have had an arterio-venous shunt or an intravascular access on either arms.
- •Subjects who have heart failure class III or IV.
- •Subjects who at the beginning of the scheduled study time experience any of the following newly developed conditions within the past 3 hours: chest pain, paralysis or numbness (face, arm or leg), trouble speaking or understanding, visual field loss in one or both eyes.
结局指标
主要结局
Sensitivity
时间窗: 1 day
To validate if the BP-monitor with AFib screening feature meets the acceptance criteria in sensitivity. Acceptance criteria is that sensitivity of the Omron BP-monitor with AFib screening feature should be statistically non-inferior to that of the primary predicate device.
Specificity
时间窗: 1 day
To validate if the BP-monitor with AFib screening feature meets the acceptance criteria in specificity. Acceptance criteria is that specificity of the Omron BP-monitor with AFib screening feature should be statistically non-inferior to that of the primary predicate device.
次要结局
未报告次要终点