An Observational Study to Assess the Efficacy of Continuous Subcutaneous Arrhythmia Monitoring Versus Conventional Ambulatory ECG-monitoring in Detecting Atrial Fibrillation in Patients After Pulmonary Vein Isolation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 6
- 主要终点
- Number of patients with atrial fibrillation detected by implantable loop recorder and number of patients with atrial fibrillation detected by conventional ambulatory electrocardiographic monitoring
研究概览
简要总结
The primary aim of the study is to assess the efficacy of continuous rhythm monitoring with an implantable loop recorder (ILR) compared to conventional ambulatory electrocardiography in detecting episodes of atrial fibrillation after pulmonary vein isolation (PVI). The secondary aim is to assess the efficacy of PVI during a two years follow-up and to assess the reliability of the implantable loop recorder in detecting atrial fibrillation.
50 patients will be enrolled into the study. After enrollment an implantable loop recorder will be implanted at least 6 weeks before scheduled PVI. All patients will be followed for 24 months after PVI. During the follow-up period a 72-hours ambulatory electrocardiographic monitoring will be performed at 1, 6, 12, 18, and 24 months. Transthoracic echocardiography will be performed at enrollment, 3, 12, and 24 months after PVI. Moreover, quality of life will be assessed at baseline, and 6 and 12 months after PVI.
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
- 30 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age => 30 to =< 70 years
- •Documentation of paroxysmal atrial fibrillation
- •Documentation of persistent atrial fibrillation of < 3 months duration termination either spontaneously or by DC cardioversion
- •Scheduled pulmonary vein isolation
- •Treatment with at least one class IC or class III antiarrhythmic drug tried
排除标准
- •Atrial fibrillation episodes > 3 months or permanent atrial fibrillation
- •No indication for pulmonary vein isolation
- •Contraindications for anticoagulation treatment
- •No informed consent
结局指标
主要结局
Number of patients with atrial fibrillation detected by implantable loop recorder and number of patients with atrial fibrillation detected by conventional ambulatory electrocardiographic monitoring
时间窗: 12 months
次要结局
- Number of asymptomatic and symptomatic atrial fibrillation episodes(12 months)
- Number of symptomatic and asymptomatic atrial fibrillation episodes(12 months)
研究者
Axel Brandes
Associate Professor
Odense University Hospital
