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

NCT05431972 | Completed

• 1 other identifier: SOLO-ESUS
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

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.

Conditions

Embolic Stroke of Undetermined Source

Keywords

Embolic stroke of undetermined source; left ventricle enlargement; paroxysmal atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• AF burden(F)

  1 week

• Number of other dysrhythmia

  1 week

Study Arms (2)

Cardea SOLO

EXPERIMENTAL

for 7 day holter monitor (patch type)

Device: Cardea SOLO

12 Lead EKG

ACTIVE COMPARATOR

(traditional EKG for under 2 minutes)

Device: 12 Lead EKG

Interventions

Cardea SOLO DEVICE

Neurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO

Cardea SOLO

12 Lead EKG DEVICE

Neurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO

12 Lead EKG

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

BumJoon Kim

Seoul, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, Multi-center, Open-label, Randomized, Controlled, Investigator-Initiated Trial

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 24, 2022
• Study Start: November 1, 2022
• Primary Completion: September 13, 2024
• Study Completion: September 13, 2024
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

KR (1)