Risk of Stroke and Silent Cerebrovascular Thromboembolism After Cardioversion of Atrial Fibrillation

Study Overview
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Brief Summary
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Patients with atrial fibrillation undergoing cardioversion will be randomized to undergo transesophageal echocardiography or they will receive warfarin for 3 weeks with an international normalized ratio (INR) value between 2.0-3.0. Those who do not want to use warfarin will be given an approved new oral anticoagulant agent istead of warfarin for 3 weeks. If thrombus is detected in left atrium or in left atrial appendage, no cardioversion will be performed. Other patients in the both groups will undergo electrical cardioversion. After the procedures all the patients will be given oral anticoagulant for at least 4 Weeks. All patients will have neurological examination and diffusion magnetic resonance imaging (MRI) at baseline and at postprocedural 7th day. Clinical and subclinical cerebral thromboembolic events detected by diffusion MRI will be recorded. Any bleeding events will also be recorded.

Official Title
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Does Cardioversion of Atrial Fibrillation Increase the Risk of Stroke and Silent Cerebrovascular Thromboembolism? Comparison of the Two Cardioversion Methods

Conditions
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Atrial Fibrillation, Cardioversion, Cerebrovascular Stroke

Intervention / Treatment
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* Procedure: Cardioversion
* Drug: Oral Anticoagulant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with the age of more than 18 years who are planned to undergo electrical or medical cardioversion Exclusion Criteria: Urgent cardioversion Patients who have implanted pace-makers or other metal devices Claustrophobia Hematological disorders disabling patients to receive anticoagulant agents Atrial fibrillation secondary to temporary causes. Serious rheumatic heart valve disease Hyperthyroidism History of malignancy Left atrium diameter > 55 mm Ejection fraction < 0.25

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transesophageal Echocardiography group<br>This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion | Procedure: Cardioversion<br>* Electrical cardioversion<br>|
| Active Comparator: Oral anticoagulant Group<br>This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion. | Procedure: Cardioversion<br>* Electrical cardioversion<br>Drug: Oral Anticoagulant<br>* warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any clinical thromboembolic or hemorrhagic event, death or silent cerebral thromboemboli | Clinical events during 2 years follow-up or silent cerebral thromboemboli detected by diffusion magnetic resonance imaging at 1 week post-cardioversion | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, conversion, stroke