Validation of the Modified Microlife Blood Pressure Monitor in Patients With Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Percentage of patients who are identified as not having atrial fibrillation by both the pacemaker and the Microlife device (%)
研究概览
简要总结
This study will use an automated blood pressure monitor (Microlife WatchBP03) with an inbuilt algorithm to detect atrial fibrillation (an irregular heart rhythm) in patients with an implanted pacemaker who have previously documented paroxysmal (intermittent) atrial fibrillation. This study will compare the Microlife device detected atrial fibrillation episodes to the pacemaker detected atrial fibrillation episodes.
详细描述
The modified Microlife blood pressure monitor is able to detect atrial fibrillation (AF) with high sensitivity (95%) and specificity (86%) and has a positive predictive value of 68% and negative predictive value of 98% for single readings. In addition, the modified device was also able to accurately classify the majority of the anomalous non-AF rhythms, although the specificity was highly variable, dependent upon the rhythm. However sinus rhythm was detected with a specificity of 97%. However, we do not currently know if the device would demonstrate a similar sensitivity in detecting AF in patients with paroxysmal AF.
Therefore, the present study will assess the sensitivity and specificity of the automated oscillometric device using a new AF algorithm among pacemaker patients with fast AF and atrial high-rate episodes and evaluate the effect of the specific rhythm abnormalities on the specificity for AF.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an implanted pacemaker for sick sinus syndrome with previously documented AF with atrial high-rate episodes
排除标准
- •Any patient who's pacemaker has had previously documented atrial sensing or pacing problem issues
- •Patients with permanent AF
结局指标
主要结局
Percentage of patients who are identified as not having atrial fibrillation by both the pacemaker and the Microlife device (%)
时间窗: 24 hours
True negative rate (specificity)
Percentage of patients who are identified as having atrial fibrillation by both the pacemaker and the Microlife device (%)
时间窗: 24 hours
True positive rate (sensitivity)
次要结局
未报告次要终点