Risk of Stroke and Silent Cerebrovascular Thromboembolism After Cardioversion of Atrial Fibrillation "AFTER-CV"

Recruiting

Phase 4 Results N/A

Trial Description

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.
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. 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 during this period will also be recorded.

Conditions

Interventions

  • Warfarin (Coumadin┬«)Drug
    Other Names: Coumadin; Acenocoumarol
    Intervention Desc: warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage
    ARM 1: Kind: Experimental
    Label: Warfarin Group
    Description: This arm includes the patients with atrial fibrillation who take warfarin four weeks before electrical cardioversion.
  • Cardioversion Procedure
    Intervention Desc: Electrical or medical cardioversion and spontaneous sinus rhythm return
    ARM 1: Kind: Experimental
    Label: Transesophageal Echocardiography group
    Description: This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion
    ARM 2: Kind: Experimental
    Label: Warfarin Group
    Description: This arm includes the patients with atrial fibrillation who take warfarin four weeks before electrical cardioversion.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Stroke 1 week Yes
Secondary silent cerebral thromboemboli 1 week Yes
Secondary bleeding 1 week Yes

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