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

Sponsored by Asan Medical Center

About this trial

Last updated 2 years ago

Study ID

SOLO-ESUS

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
19+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 5 months ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

Exclusion Criteria

1. Transient cerebral ischemic attack 2. Active cancer 3. Heart embolism, stroke of major heart embolism, stroke high-risk disease 4. Left atrial thrombus 5. Left ventricular thrombus 6. Sick sinus syndrome 7. Myocardiac infarction in 1 month 8. Rheumatic left atrioventricular valve or aortic valve disease 9. Artificial heart valve 10. Myocardiac infarction (EF<28%) 11. Congestive heart failure (EF<30%) 12. Dilated cardiomyopathy 13. Nonbacterial thrombotic endocarditis 14. Endocarditis 15. Intracardiac mass 16. Atrial fibrillation 17. Restriction for echocardiography (obesity, lung disease etc) 18. High risk PFO 19. Patch apply difficulty(skin allergy, ulticaria, atopic dermatitis, hyperhidrosis) 20. Implant cardiac pacemaker 21. Life-threatening arrhythmia 22. Radiation therapy or MRI scan 23. Restriction for Cardia SOLO attachment 24. The person who investigator judged unsuitable for the trial

Locations

Location

Status

Recruiting