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

Asan Medical Center

Status: Enrolling

Conditions: Embolic Stroke of Undetermined Source

Treatments: Device: 12 Lead EKG; Device: Cardea SOLO

Study type: Interventional

Funder types: Other

Identifiers

NCT05431972

SOLO-ESUS

Details and patient eligibility

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.

Full 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.

Enrollment: 370 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

370 participants in 2 patient groups

Cardea SOLO

Experimental group

Description:

for 7 day holter monitor (patch type)

Treatment:

Device: Cardea SOLO

12 Lead EKG

Active Comparator group

Description:

(traditional EKG for under 2 minutes)

Treatment:

Device: 12 Lead EKG