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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.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01924065

First Posted: August 16, 2013

Last Update Posted: January 19, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Mehmet Ozaydin, MD, Suleyman Demirel University

Purpose

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:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation Blood Thinners

U.S. FDA Resources

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

Eligibility

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

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 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

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

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


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 Submitted:	August 7, 2013
First Posted:	August 16, 2013
Last Update Posted:	January 19, 2017
Last Verified:	January 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

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