BEAT AF - Braking Ectopic Atrial Trends In Atrial Fibrillation
Trial Parameters
Brief 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
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 bilatera