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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Mehmet Ozaydin, MD, Suleyman Demirel University Identifier:
First received: August 7, 2013
Last updated: January 18, 2017
Last verified: January 2017

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 during this period will also be recorded.

Condition Intervention Phase
Atrial Fibrillation Cardioversion Cerebrovascular Stroke Procedure: Cardioversion Drug: Oral Anticoagulant Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Mehmet Ozaydin, MD, Suleyman Demirel University:

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

Secondary Outcome Measures:
  • bleeding [ Time Frame: 1 week ]
    Any bleeding

  • Clinical thromboembolic events [ Time Frame: 1 week ]
  • Any clinical thromboembolic or hemorrhagic event [ Time Frame: 1 month ]

Enrollment: 108
Study Start Date: August 2013
Estimated Study Completion Date: June 2017
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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 enabling 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier: NCT01924065     History of Changes
Other Study ID Numbers: ozaydin291
Study First Received: August 7, 2013
Last Updated: January 18, 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
Anticoagulants processed this record on September 19, 2017