Safety Study on Stopping Anticoagulation Medication in Patients With a History of Atrial Fibrillation

Study Overview
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Brief Summary
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The purpose of this study is to determine whether it is safe to stop anticoagulation medication in patients with a history of atrial fibrillation (AF) based on information from a pacemaker or implantable cardioverter defibrillator (ICD).

Official Title
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Pilot Study: Tailored Anticoagulation for Noncontinuous AF

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: Drug (Direct thrombin or Factor Xa inhibitor)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has a St Jude Medial device that is compatible with Merlin.net (remote monitoring) Patient has history of atrial fibrillation (non-continuous) Patient must be taking a a blood thinner medication other than warfarin or aspirin for atrial fibrillation Patient is willing to complete a questionnaire Exclusion Criteria: Patient is in atrial fibrillation all of the time Patient has a history of stroke or blood clot Patient is on warfarin or coumadin Patient cannot be taken off of his blood thinner medication due to another medical condition Patient is not capable of sending a remote device transmission to doctor once a week

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Remote transmissions were scheduled per each institution's device monitoring protocol. Anticoagulation was initiated/discontinued based on standard of care/guidelines as prescribed by doctor | |
| Experimental: Tailored Anticoagulation (TAC)<br>Anticoagulation was initiated or discontinued based on atrial tachycardia / atrial fibrillation (AT/AF) burden as assessed through frequent remote transmissions via Merlin.net. Patients sent in biweekly remote transmissions, automatic alert-triggered transmissions for AT/AF burden above a set threshold, and unscheduled patient-activated transmissions as needed | Other: Drug (Direct thrombin or Factor Xa inhibitor)<br>* Patient will stop or restart drug per cardiac device information (AT/AF diagnostics for prespecified AT/AF episode duration per day and total burden).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Cumulative Days on Anticoagulation | To assess the reduction in time on anticoagulation, the cumulative total number of days on anticoagulation for each group throughout the follow-up period was determined. This study was designed as a pilot/feasibility study and therefore was not powered to detect thromboembolic events. Per study protocol, all patients completed a 30 day run-in period following enrollment during which anticoagulation could not be stopped regardless of AT/AF burden. | one year |