BEAT AF - Braking Ectopic Atrial Trends In Atrial Fibrillation
Paroxysmal Atrial Fibrillation
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation
Eligibility Criteria
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
Sites / Locations
- Tel Aviv Sourasky Medical CenterRecruiting
- Clalit Health Services (HMO)
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
RR2 wearable home-care: active device
RR2 wearable home-care: sham control device
Real stimulation with RR2 neuromodulation device
Mock sham stimulation with RR2 neuromodulation device