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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Suleyman Demirel University
Information provided by (Responsible Party):
Mehmet Ozaydin, MD, Suleyman Demirel University Identifier:
First received: August 7, 2013
Last updated: April 19, 2016
Last verified: April 2016

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.

Condition Intervention Phase
Atrial Fibrillation
Cerebrovascular Stroke
Procedure: Cardioversion
Drug: warfarin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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 Suleyman Demirel University:

Primary Outcome Measures:
  • Stroke [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    ischemic or hemorrhagic strokes will be recorded

Secondary Outcome Measures:
  • silent cerebral thromboemboli [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    silent cerebral thromboemboli detected by diffusion magnetic resonance imaging

  • bleeding [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Any bleeding

Estimated Enrollment: 120
Study Start Date: August 2013
Estimated Study Completion Date: December 2016
Estimated 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 or medical cardioversion and spontaneous sinus rhythm return
Active Comparator: Warfarin Group
This arm includes the patients with atrial fibrillation who take warfarin or oral anticoagulant agents four weeks before electrical cardioversion.
Procedure: Cardioversion
Electrical or medical cardioversion and spontaneous sinus rhythm return
Drug: warfarin
warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders 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 Recruiting
Isparta, Mediterranean Region, Turkey, 32260
Contact: Abdullah Dogan, Proffesor,MD    +0902462324479 ext 1140   
Principal Investigator: Mehmet Ozaydin, Proffesor,MD         
Sub-Investigator: İbrahim Ersoy, MD         
Sponsors and Collaborators
Suleyman Demirel University
Principal Investigator: Mehmet Ozaydin, Proffesor,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: April 19, 2016
Health Authority: Turkey: Ethics Committee

Keywords provided by 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 January 17, 2017