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

Last updated: April 4, 2023
Sponsor: Asan Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dysrhythmia

Cerebral Ischemia

Chest Pain

Treatment

N/A

Clinical Study ID

NCT05431972
SOLO-ESUS
  • Ages > 19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 theintracranial/external arteries supplied to the ischemic site
  • c. During continuous monitoring or halter monitoring In the stroke intensive careunit, Person without atrial fibrillation and persistent atrial fibrillation
  • d. When checked the Transthoracic echocardiography, No major risk cardioembolic sourceof embolism. (ex. Myocardial infarction within 4 weeks, mitral stenosis, artificialheart valve and so on)
  • e. NO other specific cause of stroke identified(et, arteritis, dissection and drugabuse)
  1. cardioembolism is classified by TOAST classification.
  2. Left ventricle Enlargement(male >40mm, female >38mm, LAVI >35ml/m2
  3. Voluntarily sign the consent form

Exclusion

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

Study Design

Total Participants: 370
Study Start date:
November 01, 2022
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • BumJoon Kim

    Seoul,
    Korea, Republic of

    Active - Recruiting

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