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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Actual Primary Completion Date :	August 2017
Estimated Study Completion Date :	August 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Criteria

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Turkey
Suleyman Demirel University
Isparta, Mediterranean Region, Turkey, 32260

Sponsors and Collaborators

Suleyman Demirel University

Investigators

Principal Investigator:	Mehmet Ozaydin, Professor,MD	Suleyman Demirel University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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:

Stroke; Atrial Fibrillation; Thromboembolism; 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