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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01924065
Other study ID # ozaydin291
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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