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临床试验/NCT00697359
NCT00697359已完成不适用

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

Odense University Hospital6 个研究点 分布在 3 个国家目标入组 57 人开始时间: 2008年6月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Axel Brandes

Associate Professor

Odense University Hospital

研究点 (6)

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