A Study of Intermittent Photoplethysmography Based Rhythm Monitoring for Detection of Atrial Fibrillation Recurrence After Pulmonary Vein Isolation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- AF detection rate with PPG-monitoring vs standard of care monitoring after the blanking period in the first-year post AF ablation
研究概览
简要总结
Recurrence of atrial fibrillation (AF) after a pulmonary vein isolation (PVI) procedure is frequent. Current follow up with Holter monitoring and electrocardiograms (ECG) during outpatient clinic consultations cover only short time stretches and require hospital visits. Mobile health solutions with rhythm monitoring using photoplethysmography (PPG) technology on a smartphone could extend rhythm monitoring time, while lowering hospital visits and cost. This study aims to compare the performance of a digital health solution using PPG technology on a smartphone versus the current standard of care to monitor for AF recurrence after a PVI procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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 scheduled for an ablation procedure for AF, at least 4 weeks after the inclusion.
- •Subject provides informed consent.
- •Subject understands and agrees to comply with planned study procedures.
- •Subject is able to perform measurements of the heart rhythm using the FibriCheck application at home.
排除标准
- •Insufficient cognitive or comprehensive level of Dutch to participate to the trial.
- •No access to a smartphone or unable to perform FibriCheck measurements at home.
- •Pacemaker.
研究组 & 干预措施
Study group
All subjects will receive both standard of care monitoring and digital rhythm monitoring using a PPG based smartphone application for AF recurrence after the PVI procedure.
干预措施: Digital Monitoring (Diagnostic Test)
Study group
All subjects will receive both standard of care monitoring and digital rhythm monitoring using a PPG based smartphone application for AF recurrence after the PVI procedure.
干预措施: Standard of care (Diagnostic Test)
结局指标
主要结局
AF detection rate with PPG-monitoring vs standard of care monitoring after the blanking period in the first-year post AF ablation
时间窗: 1 year
次要结局
- Proportion of confirmed symptom-rhythm correlations by PPG-monitoring vs standard care monitoring in patients who report symptoms on outpatient consultations.(1 year)
- The number and dispersion of PPG measurements needed to achieve similar sensitivity with intermittent one-minute PPG measurements compared to one 24h-Holter.(1 year)
- Sensitivity, specificity and accuracy of PPG rhythm monitoring for AF detection during 24h-Holter monitoring on PPG measurement level.(1 year)
- Predictive value of AF detection with PPG during blanking period for AF recurrence.(1 year)
- Time to detection of AF after PVI (and after the blanking period) with PPG monitoring vs standard of care monitoring.(1 year)
研究者
Laurent Pison
Clinical professor
Ziekenhuis Oost-Limburg