Does Cardioversion of Atrial Fibrillation Increase the Risk of Stroke and Silent Cerebrovascular Thromboembolism? Comparison of the Two Cardioversion Methods
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Combined Clinical Thromboembolic or Hemorrhagic Event, Death or Silent Cerebral Thromboemboli
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with the age of more than 18 years who are planned to undergo electrical or medical cardioversion
排除标准
- •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
研究组 & 干预措施
Transesophageal Echocardiography group
This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion
干预措施: Cardioversion (Procedure)
Oral anticoagulant Group
This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion.
干预措施: Cardioversion (Procedure)
Oral anticoagulant Group
This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion.
干预措施: Oral Anticoagulant (Drug)
结局指标
主要结局
Combined Clinical Thromboembolic or Hemorrhagic Event, Death or Silent Cerebral Thromboemboli
时间窗: 2 years
Clinical events during 2 years follow-up or silent cerebral thromboemboli detected by diffusion magnetic resonance imaging at 1 week post-cardioversion
Acute Ischemia in MRI
时间窗: 1 week
Development of acute silent cerebral ischemia detected by MRI
Efficacy Clinical End-point
时间窗: 2 years
Any Clinical Thromboembolic Event, Death or Silent Cerebral Thromboemboli
Ischemic Stroke/Transient Ischemic Attack
时间窗: 2 years
Mortality
时间窗: 2 years
Hemorrhagic Stroke
时间窗: 2 years
Gastrointestinal Bleeding
时间窗: 2 years
次要结局
未报告次要终点
研究者
Mehmet Ozaydin, MD
MD, Professor in Cardiology
Suleyman Demirel University