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RECRUITING
NCT05872776
NA

BEAT AF - Braking Ectopic Atrial Trends In Atrial Fibrillation

Sponsor: Ziv HealthCare Ltd.

View on ClinicalTrials.gov

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

Interventions

DEVICE

Neuromodulation with RR2 device

non-invasive neuromodulation with RR2 device

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