Cardea SOLOTM for Paroxysmal Atrial Fibrillation Diagnosis in ESUS Patients With Left Atrial Enlargement

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.

Inclusion criteria

Inclusion NO. 3 or 4 must be satisfied, and No. 2, 5 and 6 must be satisfied.

• On the Screening date, Stroke onset date is not over 60 days.

• 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)

• cardioembolism is classified by TOAST classification.

• Left ventricle Enlargement(male >40mm, female >38mm, LAVI >35ml/m2

• Voluntarily sign the consent form

Exclusion criteria

• 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