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

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

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.

Study Overview

• Status: Completed
• Conditions: Embolic Stroke of Undetermined Source
• Intervention / Treatment: Device: Cardea SOLO; Device: 12 Lead EKG

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.

• Study Type: Interventional
• Enrollment (Actual): 257
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • BumJoon Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): September 13, 2024
• Study Completion (Actual): September 13, 2024

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 7, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: paroxysmal atrial fibrillation; Embolic stroke of undetermined source; left ventricle enlargement
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Electrodiagnosis; Electrocardiography
• Other Study ID Numbers: SOLO-ESUS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No