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BEAT AF - Braking Ectopic Atrial Trends In Atrial Fibrillation
Sponsor: Ziv HealthCare Ltd.
Summary
Paroxysmal AF subjects with a documented ECG event of AF will be recruited to the study To assess the efficacy of CardiaCare™ RR2 wearable home-care neuromodulation system in reducing AF burden and symptoms in Paroxysmal AF patients
Official title: A Multi Center Randomized, Double Blinded, Sham Controlled, Clinical Study Aimed to Determine the Efficacy of CardiaCare™ RR2 Home-care Neuromodulation System in Reducing Atrial Fibrillation Burden and Symptoms in Paroxysmal AF Patients
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2023-02-16
Completion Date
2025-03
Last Updated
2024-06-20
Healthy Volunteers
No
Conditions
Interventions
Neuromodulation with RR2 device
non-invasive neuromodulation with RR2 device
Mock sham neuromodulation with sham RR2 device
Mock sham stimulation with RR2 device
Locations (2)
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Clalit Health Services (HMO)
Tel Aviv, Israel