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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Embolic Stroke of Undetermined Source

Intervention / Treatment
-----------------
* Device: Cardea SOLO
* Device: 12 Lead EKG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, Multi-center, Open-label, Randomized, Controlled, Investigator-Initiated Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardea SOLO<br>for 7 day holter monitor (patch type) | Device: Cardea SOLO<br>* Neurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO<br>|
| Active Comparator: 12 Lead EKG<br>(traditional EKG for under 2 minutes) | Device: 12 Lead EKG<br>* Neurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients number with AF over 30 seconds of cardea SOLO / with AF with 1 time of 12 lead EKG | cardea SOLO and 12 lead EKG is different | 30 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF burden(F) | cardea SOLO and 12 lead EKG is different | 1 week | 
| Number of other dysrhythmia | cardea SOLO and 12 lead EKG is different | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Embolic stroke of undetermined source, left ventricle enlargement, paroxysmal atrial fibrillation