Comparison of External Event Recorders for Atrial Fibrillation Monitoring

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of External Event Recorders With Implantable Monitor for Post Atrial Fibrillation Monitoring: Assessment of Cost and Efficacy

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Standard Event Monitor
* Device: Sleuth Monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects who undergo radiofrequency ablation of paroxysmal AF. Exclusion Criteria: Subjects with known allergy to sticky patches of event monitor Subjects with skin infection or other problems on the chest that interferes with monitor implantation Subjects who are scheduled for radiation therapy Subjects who are scheduled for therapeutic ultrasound (like lithotripsy) Subjects who are scheduled for MRI Subjects who are scheduled for a procedure that uses diathermy. Subjects, in the opinion of the investigator, are not suitable candidates for the study Subjects that do not have analog telephone line at home. Existing Cardiac Rhythm Management Device (e.g., pacemaker or ICD)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Standard Event Monitor | Device: Standard Event Monitor<br>* Standard Event Monitor<br>|
| Active Comparator: 2<br>Sleuth recorder | Device: Sleuth Monitor<br>* Implantable Sleuth Recorder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence of atrial fibrillation |  | 6 months, 1 year, 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost-effectiveness ratio (ICER) between the two technologies and the 95% confidence interval for the ICER |  | 6 months, 1 year, 2 years | 
| percentage of patients whose Coumadin is stopped prematurely due to inappropriate assumption of rhythm control |  | 6 months, 1 year, 2 years | 
| percentage of patients who develop symptoms of stroke or transient ischemic attacks during follow up |  | 6 months, 1 year, 2 years | 
| cost differences in follow up care between the two groups |  | 6 months, 1 year, 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation