BEAT AF - Braking Ectopic Atrial Trends In Atrial Fibrillation

Ziv HealthCare

Status: Enrolling

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Device: Neuromodulation with RR2 device; Device: Mock sham neuromodulation with sham RR2 device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05872776

CAR-POC-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women ages 18-85 years with history of documented paroxysmal (<7 days) atrial fibrillation
• AF Burden (% time in AF) of more than 0.5% and less than 25% as evident by a continuous 14 days ECG recording at baseline (at minimum 168 hours)
• Ability and willingness to sign an informed consent form
• Ability and willingness to use CardiaCare home care device and ECG chest patch and has an available smart phone
• Known symptomatic AF event over the recent 3 months
• Willing not to change the antiarrhythmic treatment

Exclusion criteria

• Hemodynamic instability (systolic blood pressure <100mmHg or heart rate>170 bpm at Baseline) during recruitment visit
• Known history or current diagnosis of atrial flutter
• An active myocardial infarction evident from ECG
• Recent stroke or myocardial infarction (<6 months)
• History of sick sinus syndrome 2nd or 3rd degree AV block, bifascicular block or prolonged (PR>300ms) 1st degree AV block
• Unilateral or bilateral vagotomy
• History of persistent AF with documented AF episodes of >7 days
• Significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases or valvular AF)
• History of Impaired systolic function with EF<40 % or NY Class III or IV heart failure classification
• Dilatated left atria with a diameter > 50mm as evident by an echocardiogram
• Currently enrolled in another study
• Recurrent vaso-vagal syncopal episodes
• Pregnancy or breast feeding
• Pacemaker or CRTD or any implanted electrical stimulating device
• History of epilepsy or seizures
• Peripheral neuropathy or dermatological condition affecting the tested upper extremity area
• Unsuitable for participating in the study according to attending physician

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

RR2 wearable home-care: active device

Active Comparator group

Description:

Real stimulation with RR2 neuromodulation device

Treatment:

Device: Neuromodulation with RR2 device

RR2 wearable home-care: sham control device

Sham Comparator group

Description:

Mock sham stimulation with RR2 neuromodulation device

Treatment:

Device: Mock sham neuromodulation with sham RR2 device