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

Atrial Fibrillation Clinical Trial

— AFTER-CV  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01924065
• Other study ID #: ozaydin291
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 2013
• Est. completion date: July 2021

Study information

• Verified date: March 2021
• Source: Suleyman Demirel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 108
• Est. completion date: July 2021
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardioversion
• Cerebrovascular Stroke
• Stroke
• Thromboembolism

Intervention

Procedure:
• Cardioversion
Electrical cardioversion

Drug:
• Oral Anticoagulant
warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage

Locations

Country	Name	City	State
Turkey	Suleyman Demirel University	Isparta	Mediterranean Region

Sponsors (1)

Lead Sponsor	Collaborator
Suleyman Demirel University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any clinical thromboembolic or hemorrhagic event, death or silent cerebral thromboemboli	Clinical events during 2 years follow-up or silent cerebral thromboemboli detected by diffusion magnetic resonance imaging at 1 week post-cardioversion	2 years