NCT05431972已完成不适用
Efficacy and Safety of Cardea SOLOTM for Paroxysmal Atrial Fibrillation Diagnosis in ESUS Patients With Left Atrial Enlargement: Prospective, Multi-center, Open-label, Randomized, Controlled, Investigator-Initiated Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 257
- 试验地点
- 1
- 主要终点
- Patients number with AF over 30 seconds of cardea SOLO / with AF with 1 time of 12 lead EKG
研究概览
简要总结
The aim of the study is to evaluate the efficacy and safety of the Cardea SOLO Compared to 12 lead EKG for Paroxysmal Atrial Fibrillation Diagnosis in ESUS patients with Left Atrial Enlargement.
详细描述
The Prospective, Multi-center, Open-label, Randomized, Controlled, Investigator-Initiated Trial will be started on June 2022. Randomized patients in two arms will receive Cardea SOLO or 12 lead EKG respectively. Cardea SOLO received patients will keep it for 7 days. 12 lead EKG received patients will discharge home. After 7 days, Results of Cardea SOLO auto reading will be evaluated by dependent committee including cardiologist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion NO. 3 or 4 must be satisfied, and No. 2, 5 and 6 must be satisfied.
- •2. On the Screening date, Stroke onset date is not over 60 days.
- •3. ESUS Diagnosis : all of a~e must be satisfied.
- •a. Ischemic stroke detected by CT or MRI that is not lacunar
- •b. A person without arteriosclerosis which causes at least 50% stenosis of the intracranial/external arteries supplied to the ischemic site
- •c. During continuous monitoring or halter monitoring In the stroke intensive care unit, Person without atrial fibrillation and persistent atrial fibrillation
- •d. When checked the Transthoracic echocardiography, No major risk cardioembolic source of embolism. (ex. Myocardial infarction within 4 weeks, mitral stenosis, artificial heart valve and so on)
- •e. NO other specific cause of stroke identified(et, arteritis, dissection and drug abuse)
- •4. cardioembolism is classified by TOAST classification.
- •5. Left ventricle Enlargement(male >40mm, female >38mm, LAVI >35ml/m2
- •6. Voluntarily sign the consent form
排除标准
- •Transient cerebral ischemic attack
- •Active cancer
- •Heart embolism, stroke of major heart embolism, stroke high-risk disease
- •Left atrial thrombus
- •Left ventricular thrombus
- •Sick sinus syndrome
- •Myocardiac infarction in 1 month
- •Rheumatic left atrioventricular valve or aortic valve disease
- •Artificial heart valve
- •Myocardiac infarction (EF<28%)
- •Congestive heart failure (EF<30%)
- •Dilated cardiomyopathy
- •Nonbacterial thrombotic endocarditis
- •Endocarditis
- •Intracardiac mass
- •Atrial fibrillation
- •Restriction for echocardiography (obesity, lung disease etc)
- •High risk PFO
- •Patch apply difficulty(skin allergy, ulticaria, atopic dermatitis, hyperhidrosis)
- •Implant cardiac pacemaker
- •Life-threatening arrhythmia
- •Radiation therapy or MRI scan
- •Restriction for Cardia SOLO attachment
- •The person who investigator judged unsuitable for the trial
结局指标
主要结局
Patients number with AF over 30 seconds of cardea SOLO / with AF with 1 time of 12 lead EKG
时间窗: 30 seconds
cardea SOLO and 12 lead EKG is different
次要结局
- Number of other dysrhythmia(1 week)
- AF burden(F)(1 week)
研究者
Bum Joon Kim
Professor
Asan Medical Center
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Comparison of Paclitaxel-Eluting Coroflex Please Stent Versus Paclitaxel-Eluting StentCoronary Artery DiseaseNCT00995423CardioVascular Research Foundation, Korea500
已完成
不适用
Cala ONE Device for Essential TremorEssential TremorNCT02629614Cala Health, Inc.93
已完成
2 期
Evaluation of the Efficacy and Safety of Clazosentan in Reversing Cerebral Vasospasm in Adult Subjects With Aneurysmal Subarachnoid HemorrhageAneurysmal Subarachnoid HemorrhageNCT02560532Idorsia Pharmaceuticals Ltd.25
Unknown
不适用
The Efficacy and Safety of SeQuent® Please in the Treatment of Small Vessel Disease (SVD) PatientSmall Vessel DiseaseNCT03625830B. Braun Medical International Trading Company Ltd.270
终止
不适用
Comparison of the Conor Sirolimus-eluting Coronary Stent to the Taxus Liberte Paclitaxel-eluting Coronary Stent in the Treatment of Coronary Artery LesionsCoronary AtherosclerosisNCT00606333Cordis Corporation394