At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Does Cardioversion of Atrial Fibrillation Increase the Risk of Stroke and Silent Cerebrovascular Thromboembolism? Comparison of the Two Cardioversion Methods
In Brief
A Phase 3 clinical trial evaluating Cardioversion and Oral Anticoagulant for Atrial Fibrillation and 2 related conditions. Completed, enrolled 112 participants across 1 site.
Detailed Summary
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 Details
Timeline
Interventions
Electrical cardioversion
warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage