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

Embolic Stroke of Undetermined Source Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05431972
• Other study ID #: SOLO-ESUS
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Asan Medical Center
• Contact: BumJoon Kim, PhD
• Phone: +82-10-8951-3755
• Email: bj.kim[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 370
• Est. completion date: December 31, 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Embolic Stroke
• Embolic Stroke of Undetermined Source
• Hypertrophy

Intervention

Device:
• Cardea SOLO
Neurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO
• 12 Lead EKG
Neurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO

Locations

Country	Name	City	State
Korea, Republic of	BumJoon Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	AF burden(F)	cardea SOLO and 12 lead EKG is different	1 week
Secondary	Number of other dysrhythmia	cardea SOLO and 12 lead EKG is different	1 week