Implantable Loop Recorder Versus Conventional Ambulatory Monitoring in Detecting Atrial Fibrillation After Pulmonary Vein Isolation
- Conditions
- Atrial Fibrillation
- Interventions
- Device: Implantable loop recorder (ILR)
- Registration Number
- NCT00697359
- Lead Sponsor
- Odense University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
- 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
- Atrial fibrillation episodes > 3 months or permanent atrial fibrillation
- No indication for pulmonary vein isolation
- Contraindications for anticoagulation treatment
- No informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Implantable loop recorder (ILR) There is only one group in this cohort study.
- Primary Outcome Measures
Name Time Method Number of patients with atrial fibrillation detected by implantable loop recorder and number of patients with atrial fibrillation detected by conventional ambulatory electrocardiographic monitoring 12 months
- Secondary Outcome Measures
Name Time Method Number of asymptomatic and symptomatic atrial fibrillation episodes 12 months Number of symptomatic and asymptomatic atrial fibrillation episodes 12 months
Trial Locations
- Locations (3)
Odense University Hospital
🇩🇰Odense, Denmark
Örebro University Hospital
🇸🇪Örebro, Sweden
Academician E. N. Meshalkin
🇷🇺Novosibirsk, Russian Federation