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 instead 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
112
Electrical cardioversion
warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage
Suleyman Demirel University
Isparta, Mediterranean Region, Turkey (Türkiye)
Combined 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
Time frame: 2 years
Efficacy Clinical End-point
Any Clinical Thromboembolic Event, Death or Silent Cerebral Thromboemboli
Time frame: 2 years
Ischemic Stroke/Transient Ischemic Attack
Time frame: 2 years
Acute Ischemia in MRI
Development of acute silent cerebral ischemia detected by MRI
Time frame: 1 week
Mortality
Time frame: 2 years
Hemorrhagic Stroke
Time frame: 2 years
Gastrointestinal Bleeding
Time frame: 2 years
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