BEAT AF - Braking Ectopic Atrial Trends In Atrial Fibrillation

Status Recruiting

Clinical Trial 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

Clinical Trial Description

After screening for 14 days with a continuous ECG monitoring device, eligible patients will be randomized to either active treatment or a sham treatment groups. For a treatment period of 12 weeks, patients will be prompted to self-conduct neuromodulation sessions based on: a. predetermined treatment regimen plus b. a detection algorithm. In addition, participants will measure at home, daily 2 min ECG's with the RR2 system two times a day and when feeling symptoms suspected as AF/AT/SVT or PAC's. After 10 weeks of treatment patients will be requested to wear an ECG patch continuously for an additional period of 14 days. Overall patients will participate in the study for 14 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05872776
Study type	Interventional
Source	Ziv HealthCare Ltd.
Contact	Adi Benari, MSc
Phone	+972-52-3863087
Email	adi.b@my-cardiacare.com
Status	Recruiting
Phase	N/A
Start date	February 16, 2023
Completion date	March 2025

View Details

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