NCT05872776

BEAT AF - Braking Ectopic Atrial Trends In Atrial Fibrillation

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Ziv HealthCare Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-02-16
• Primary completion: 2024-12-01
• Completion: 2025-03-01
• First posted: 2023-05-24
• Last updated: 2024-06-20

Locations

2 sites across 1 country: Israel