NCT01924065

Risk of Stroke and Silent Cerebrovascular Thromboembolism After Cardioversion of Atrial Fibrillation

Does Cardioversion of Atrial Fibrillation Increase the Risk of Stroke and Silent Cerebrovascular Thromboembolism? Comparison of the Two Cardioversion Methods

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Suleyman Demirel University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 instead 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.

Conditions

• Atrial Fibrillation
• Cardioversion
• Cerebrovascular Stroke

Interventions

Type	Name	Description
PROCEDURE	Cardioversion	Electrical cardioversion
DRUG	Oral Anticoagulant	warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage

Timeline

• Start date: 2013-08-01
• Primary completion: 2017-08-01
• Completion: 2024-10-29
• First posted: 2013-08-16
• Last updated: 2024-11-15
• Results posted: 2024-10-08

Locations

1 site across 1 country: Turkey (Türkiye)