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

NCT ID: NCT05431972

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 257 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-09-13

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.

Conditions

Embolic Stroke of Undetermined Source

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cardea SOLO

for 7 day holter monitor (patch type)

Group Type: EXPERIMENTAL

Cardea SOLO

Intervention Type: DEVICE

Neurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO

12 Lead EKG

(traditional EKG for under 2 minutes)

Group Type: ACTIVE_COMPARATOR

12 Lead EKG

Intervention Type: DEVICE

Neurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO

Interventions

Cardea SOLO

Neurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO

Intervention Type: DEVICE

12 Lead EKG

Neurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO

Intervention Type: DEVICE

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

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Bum Joon Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

BumJoon Kim

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SOLO-ESUS

Identifier Type: -

Identifier Source: org_study_id