BEAT AF - Braking Ectopic Atrial Trends In Atrial Fibrillation

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

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

Conditions2

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