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

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ClinicalTrials.gov Identifier: NCT01924065
Recruitment Status : Active, not recruiting
First Posted : August 16, 2013
Last Update Posted : November 30, 2017
Information provided by (Responsible Party):

Study Description
Brief 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 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Cardioversion Cerebrovascular Stroke Procedure: Cardioversion Drug: Oral Anticoagulant Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Cardioversion of Atrial Fibrillation Increase the Risk of Stroke and Silent Cerebrovascular Thromboembolism? Comparison of the Two Cardioversion Methods
Study Start Date : August 2013
Primary Completion Date : August 2017
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Ischemic stroke or silent cerebral thromboemboli [ Time Frame: 1 week ]
    clinical events or cerebral thromboemboli detected by diffusion magnetic resonance imaging

Secondary Outcome Measures :
  1. Any clinical thromboembolic or hemorrhagic event or death [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01924065

Suleyman Demirel University
Isparta, Mediterranean Region, Turkey, 32260
Sponsors and Collaborators
Suleyman Demirel University
Principal Investigator: Mehmet Ozaydin, Professor,MD Suleyman Demirel University
More Information

Responsible Party: Mehmet Ozaydin, MD, MD, Professor in Cardiology, Suleyman Demirel University
ClinicalTrials.gov Identifier: NCT01924065     History of Changes
Other Study ID Numbers: ozaydin291
First Posted: August 16, 2013    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017

Keywords provided by Mehmet Ozaydin, MD, Suleyman Demirel University:
Atrial fibrillation, conversion, stroke

Additional relevant MeSH terms:
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Embolism and Thrombosis