NCT05431972

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 257 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Embolic Stroke of Undetermined Source

Interventions

Type	Name	Description
DEVICE	Cardea SOLO	Neurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO
DEVICE	12 Lead EKG	Neurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-09-13
• Completion: 2024-09-13
• First posted: 2022-06-24
• Last updated: 2025-12-15

Locations

1 site across 1 country: South Korea