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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
257
Neurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO
Neurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO
BumJoon Kim
Seoul, South Korea
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
Time frame: 30 seconds
AF burden(F)
cardea SOLO and 12 lead EKG is different
Time frame: 1 week
Number of other dysrhythmia
cardea SOLO and 12 lead EKG is different
Time frame: 1 week
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