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

Phase 3

Completed

• Conditions: Atrial Fibrillation; Cerebrovascular Stroke; Cardioversion
• Interventions: Procedure: Cardioversion; Drug: Oral Anticoagulant

• Registration Number: NCT01924065
• Lead Sponsor: Suleyman Demirel University

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-07
• Study First Submitted QC: 2013-08-15
• Study First Posted: 2013-08-16
• Primary Completion: 2017-08
• Results First Submitted: 2022-08-15
• Results First Submitted QC: 2024-06-18
• Status Verified: 2024-10
• Results First Posted: 2024-10-08
• Study Completion: 2024-10-29
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transesophageal Echocardiography group	Cardioversion	This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion
Oral anticoagulant Group	Cardioversion	This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion.
Oral anticoagulant Group	Oral Anticoagulant	This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion.

Primary Outcome Measures

Name	Time	Method
Combined Clinical Thromboembolic or Hemorrhagic Event, Death or Silent Cerebral Thromboemboli	2 years	Clinical events during 2 years follow-up or silent cerebral thromboemboli detected by diffusion magnetic resonance imaging at 1 week post-cardioversion
Efficacy Clinical End-point	2 years	Any Clinical Thromboembolic Event, Death or Silent Cerebral Thromboemboli
Ischemic Stroke/Transient Ischemic Attack	2 years
Acute Ischemia in MRI	1 week	Development of acute silent cerebral ischemia detected by MRI
Mortality	2 years
Hemorrhagic Stroke	2 years
Gastrointestinal Bleeding	2 years

Trial Locations

Locations (1)

Suleyman Demirel University; 🇹🇷 Isparta, Mediterranean Region, Turkey