Randomised ELR Monitoring Against Permanent Pacemaker in Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- Sensitivity and specificity in detection of pacemaker detected AF burden in comparison to R-test
研究概览
简要总结
Randomised crossover study comparing the sensitivity and specificity of 5 External loop recorders in detecting pacemaker detected Atrial fibrillation burden.
详细描述
The purpose of the study is to compare the diagnostic accuracy of the ZIO xt , MoMe, TECHNOMED pocket ECG and Nuubo to the R-test, our current standard clinical practice, in detection of AF burden, in patients with history of Paroxysmal Atrial Fibrillation and have a dual chamber pacemaker or ICD in situ, with sensitivity and specificity of AF detection calculated from the implanted pacemaker monitored beat to beat holters.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of Atrial Fibrillation
- •Dual chamber pacemaker with advanced holter arrhythmia diagnostics
排除标准
- •Previous AV node ablation
研究组 & 干预措施
ELR monitoring
Single arm study. All participants with existing permanent dual chamber pacemakers will be monitored with 5 different Loop recorder devices for a 2 week period to assess there sensitivity and specificity in detecting AF burden. The devices used will be
- R test
- Nuubo
- TECHNOMED pocket ECG
- ZIO xt patch
- MoMe
干预措施: ZIO xt patch (Device)
ELR monitoring
Single arm study. All participants with existing permanent dual chamber pacemakers will be monitored with 5 different Loop recorder devices for a 2 week period to assess there sensitivity and specificity in detecting AF burden. The devices used will be
- R test
- Nuubo
- TECHNOMED pocket ECG
- ZIO xt patch
- MoMe
干预措施: MoMe (Device)
ELR monitoring
Single arm study. All participants with existing permanent dual chamber pacemakers will be monitored with 5 different Loop recorder devices for a 2 week period to assess there sensitivity and specificity in detecting AF burden. The devices used will be
- R test
- Nuubo
- TECHNOMED pocket ECG
- ZIO xt patch
- MoMe
干预措施: R test (Device)
ELR monitoring
Single arm study. All participants with existing permanent dual chamber pacemakers will be monitored with 5 different Loop recorder devices for a 2 week period to assess there sensitivity and specificity in detecting AF burden. The devices used will be
- R test
- Nuubo
- TECHNOMED pocket ECG
- ZIO xt patch
- MoMe
干预措施: Nuubo (Device)
ELR monitoring
Single arm study. All participants with existing permanent dual chamber pacemakers will be monitored with 5 different Loop recorder devices for a 2 week period to assess there sensitivity and specificity in detecting AF burden. The devices used will be
- R test
- Nuubo
- TECHNOMED pocket ECG
- ZIO xt patch
- MoMe
干预措施: TECHNOMED pocket ECG (Device)
结局指标
主要结局
Sensitivity and specificity in detection of pacemaker detected AF burden in comparison to R-test
时间窗: 14 weeks
Sensitivity and specificity of ZIO xt patch, MoMe, TECHNOMED pocket ECG AND Nuubo in detection of pacemaker detected AF burden in comparison to R-test. Sensitivity and sepcificity will be determined by the percentage of pacemaker detected AF episodes that have been detected by each ELR device.
次要结局
- proportion of pacemaker detected tachyarrhythmias detected in comparison to R-test(14 weeks)
- Total wear time in comparison to R-test(14 weeks)
- Proportion of symptomatic arrhythmias detected in comparison to R-test(14 weeks)
- Cost effectiveness in detection of arrhythmias in comparison to R-test(14 weeks)
研究者
Neil Sulke
Dr
Eastbourne General Hospital