Testing the Accuracy of an Intermittent Personal Heart Rhythm Monitor (PHRM) to Detect Prolonged Paroxysmal Atrial Fibrillation (PAF) Against Implantable Devices.
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- The sensitivity and specificity of detection of prolonged paroxysmal atrial fibrillation (PAF) using a Personal Heart Rhythm Monitor (PHRM), compared to an implantable device.
研究概览
简要总结
This study aims to determine the sensitivity and specificity of a Personal Heart Rhythm Monitor in the detection of prolonged paroxysmal atrial fibrillation (defined as lasting more than 12 hours) against pre-existing implantable devices, seen to be the 'gold-standard' for arrhythmia detection.
详细描述
The Investigators aim to recruit 30 volunteers with implantable devices (either conventional pacemakers, with an atrial lead or implantable loop recorders, devices inserted under the skin to monitor the heart rhythm). They will be attending for their routine pacemaker checks in a number of clinics in Surrey.
Potential participants will have documented prolonged paroxysmal atrial fibrillation (PAF, an intermittent irregular heart rhythm which is known to predispose to stroke), lasting at least 12 hours, identified in the last month prior to the pacemaker check.
Willing patients will then be issued with a PHRM (Personal Heart Rhythm Monitor) device to make heart rhythm recordings for 3 months. They will do this twice-daily for 30 seconds for this period. At the end of the 3 month period patients will undergo a final pacing device check. Identification of prolonged PAF using the PHRM device will be compared to the implantable device.
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
- Single (Outcomes Assessor)
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
- •Prolonged AF (defined as an episode at least 12 hours duration) in the last month whilst attending routine pacemaker check
- •Pacing requirement < 25% during the last month
排除标准
- •Lack of capacity
- •Inability to use the Personal Heart Rhythm Monitor due to cognitive or physical impairment
- •Commencement of new anti-arrhythmic drug since last pacemaker check
结局指标
主要结局
The sensitivity and specificity of detection of prolonged paroxysmal atrial fibrillation (PAF) using a Personal Heart Rhythm Monitor (PHRM), compared to an implantable device.
时间窗: 18 months
Measured (%) as the number of identified episodes of prolonged PAF using the PHRM compared to the gold standard implantable device in all patients over the 3 month period.
次要结局
- The sensitivity and specificity of detection of all episodes of PAF using a PHRM, compared to an implantable device.(18 months)
- The concordance of the interpretation of PHRM recordings by a Research Nurse and blinded Cardiologist.(18 months)
- Participant compliance with twice-daily recordings with the PHRM for a three month period.(18 months)