Clinical trial NCT05431972: Cardea SOLOTM for Paroxysmal Atrial Fibrillation Diagnosis in ESUS Patients With Left Atrial Enlargement
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Embolic Stroke of Undetermined Source
Keywords: Embolic stroke of undetermined source
left ventricle enlargement
paroxysmal atrial fibrillation
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 370
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Multi-center, Open-label, Randomized, Controlled, Investigator-Initiated Trial
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Patients number with AF over 30 seconds of cardea SOLO / with AF with 1 time of 12 lead EKG
timeFrame: 30 seconds
Secondary outcomes:
measure: AF burden(F)
timeFrame: 1 week
measure: Number of other dysrhythmia
timeFrame: 1 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: BumJoon Kim
Study officials:
References: