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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05431972
Recruitment Status : Not yet recruiting
First Posted : June 24, 2022
Last Update Posted : June 28, 2022
Sponsor:
Information provided by (Responsible Party):
Bum Joon Kim, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Embolic Stroke of Undetermined Source Device: Cardea SOLO Device: 12 Lead EKG Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, Multi-center, Open-label, Randomized, Controlled, Investigator-Initiated Trial
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Estimated Study Start Date : June 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cardea SOLO
for 7 day holter monitor (patch type)
Device: Cardea SOLO
Neurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO

Active Comparator: 12 Lead EKG
(traditional EKG for under 2 minutes)
Device: 12 Lead EKG
Neurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO




Primary Outcome Measures :
  1. Patients number with AF over 30 seconds of cardea SOLO / with AF with 1 time of 12 lead EKG [ Time Frame: 30 seconds ]
    cardea SOLO and 12 lead EKG is different


Secondary Outcome Measures :
  1. AF burden(F) [ Time Frame: 1 week ]
    cardea SOLO and 12 lead EKG is different

  2. Number of other dysrhythmia [ Time Frame: 1 week ]
    cardea SOLO and 12 lead EKG is different



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 30 days.

3. ESUS Diagnosis : all of a~e must be satisfied.

  • a. Ischemic stroke detected by CT or MRI that is not lacunar
  • b. Absence of extracranial or intracranial atherosclerosis causing>=50% luminal stenosis in arteries supplying the area of ischemia
  • c. no atrial fibrillation and flutter for > 24 hours cardiac rhythm monitoring
  • d. No major risk cardioembolic source of embolism.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05431972


Contacts
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Contact: BumJoon Kim, PhD +82-10-8951-3755 bj.kim@amc.seoul.kr

Locations
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Korea, Republic of
BumJoon Kim
Seoul, Korea, Republic of
Contact: BumJoon Kim    +821089513755    bj.kim@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
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Responsible Party: Bum Joon Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT05431972    
Other Study ID Numbers: SOLO-ESUS
First Posted: June 24, 2022    Key Record Dates
Last Update Posted: June 28, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Bum Joon Kim, Asan Medical Center:
Embolic stroke of undetermined source
left ventricle enlargement
paroxysmal atrial fibrillation
Additional relevant MeSH terms:
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Embolic Stroke
Atrial Fibrillation
Hypertrophy
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Pathological Conditions, Anatomical
Ischemic Stroke