Ablation of atrial fibrillation is a well established treatment method to restore normal sinus rhythm and eliminate the need for continued antiarrhythmic therapy and anticoagulation. Absence of symptomatic and asymptomatic atrial fibrillation should be considered necessary for discontinuation of anticoagulation therapy. Presently, recurrence of atrial fibrillation is usually determined with the use of a non looping event monitor which is typically used by the subject at the time of symptomatic arrhythmia. This method does not detect asymptomatic atrial fibrillation. Random asymptomatic recording can be added, but the chance for detecting recurrence of arrhythmia is not great. Too frequently, the success rates of AF ablation procedures are inflated by insufficient follow up and patient's limited compliance in reporting and recording episodes of recurrent arrhythmias. Often times, it is very inconvenient for patients to wear external event recorders. Allergies to the sticky pads that are needed for most of the external monitoring devices continues to be a problem. Implantable loop recorders have the advantage of detecting symptomatic and asymptomatic atrial fibrillation continuously. They also offer the convenience of monitoring for up to 18 to 24 months without significant patient discomfort. However, implantation and explantation of these devices involves a limited surgical procedure as well as considerable experience. In this study we attempt to assess the differences in these two types of monitoring systems in assessing the long term efficacy of AF ablation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Standard Event Monitor
Implantable Sleuth Recorder
University of Kansas Medical Center
Kansas City, Kansas, United States
recurrence of atrial fibrillation
Time frame: 6 months, 1 year, 2 years
cost-effectiveness ratio (ICER) between the two technologies and the 95% confidence interval for the ICER
Time frame: 6 months, 1 year, 2 years
percentage of patients whose Coumadin is stopped prematurely due to inappropriate assumption of rhythm control
Time frame: 6 months, 1 year, 2 years
percentage of patients who develop symptoms of stroke or transient ischemic attacks during follow up
Time frame: 6 months, 1 year, 2 years
cost differences in follow up care between the two groups
Time frame: 6 months, 1 year, 2 years
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