JPRN-jRCTs031180249进行中（未招募）4 期
STroke secondary prevention with catheter ABLation and EDoxaban for patients with non-valvular atrial fibrillation - STABLED study
Kimura Kazumi0 个研究点目标入组 250 人开始时间: 2019年3月12日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •1)Age >=20 and =<85 years at time of giving informed consent
- •2)Nonvalvular atrial fibrillation
- •3)History of ischemic stroke in previous 6 months
- •4)Current or planned treatment with edoxaban
- •5)Modified Rankin Scale (mRS) =<3
排除标准
- •1)Symptomatic paroxysmal atrial fibrillation resistant to anti-arrhythmic drugs
- •2)Presence of left atrial thrombus and/or left atrial appendage on transthoracic echocardiography, computed tomography or magnetic resonance imaging
- •3)Unable to take anticoagulation therapy for any reason, including tendency to bleed or considered at high risk for bleeding from anticoagulation therapy
- •4)Presence of severe renal disorder(estimated creatinine clearance <30 mL/min by Cockroft-Gault equation)
- •5)Previous catheter ablation or surgical intervention for atrial fibrillation
- •6)History of treatment with a left atrial appendage closure device
- •7)Left atrial diameter >=55 mm on transthoracic echocardiography
- •8)Ejection fraction =<35% on transthoracic echocardiography
- •9)Persistent Sustained AF for >=10 years
- •10)Atrial septal defect (ASD)
- •11)Pregnant or possibility of pregnancy
- •12)Unlikely to complete the study, such as due to progressive malignant tumor
- •13)Participating or planning to participate in another interventional clinical trial
- •14)Unwilling to participate
- •15)Judged as incompatible for the study by the investigators
研究者
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