Status:
COMPLETED
Cardea SOLOTM for Paroxysmal Atrial Fibrillation Diagnosis in ESUS Patients With Left Atrial Enlargement
Lead Sponsor:
Asan Medical Center
Conditions:
Embolic Stroke of Undetermined Source
Eligibility:
All Genders
19+ years
Phase:
NA
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2024
Estimated Enrollment :
257 Patients enrolled
Trial Details
Trial ID
NCT05431972
Start Date
November 1 2022
End Date
September 13 2024
Last Update
December 15 2025
Active Locations (1)
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1
BumJoon Kim
Seoul, South Korea