Peripheral Nerve Stimulation Therapy for Atrial Fibrillation

This is a three-arm, single-blinded, randomized, sham-controlled, nonsignificant risk study to assess the feasibility of reducing Atrial Fibrillation burden with peripheral nerve stimulation. The three arms include treatment with a wrist-worn neuromodulation ("wrist device"), treatment with an ear-worn neuromodulation device ("ear device") and sham stimulation with wrist-worn device that does not actually deliver stimulation ("sham device"). ECG patches will be worn on the chest to measure AF episode onset and duration ("ECG Patch"). Additionally, a wrist-worn monitoring device will be used for the measurement of heart rate (HR), heart rate variability (HRV), and other biomarkers ("Cardiac Measurement Device (CMD)"). Finally, subjects will track AF episode onset, duration, and symptom type in an AF diary.

Inclusion Criteria:At least 22 years of age and less than 80 years of ageDiagnosed with paroxysmal atrial fibrillation, as documented on ECG, trans-telephonic monitoring (TTM), cardiac event monitoring, Holter monitoring, or implantable loop recording (episodes must be longer than 30 seconds to qualify)At least one symptomatic atrial fibrillation episodes per month over the last three monthsAF burden of at least 5%, as measured within the past 3 months, with no change in AF treatment since measurementWilling to stay on stable medications for the duration of the studyAble and willing to use their smartphone to download the application associated with the Cardiac Measurement DeviceCompetent and willing to provide written, informed consent to participate in the studyExclusion Criteria:Prior cardiac ablation, or cardiac ablation planned within 6 weeks of Visit 1Cardioversion procedure performed within the last 12 weeksValvular atrial fibrillation by transthoracic echocardiographyLeft atrial anteroposterior diameter greater than 5.5 cm by transthoracic echocardiographyPrior or planned cardiac transplantation or cardiac surgeryCerebral ischemic event (stroke or transient ischemic attack) within the last 6 monthsMyocardial infarction within the last 6 monthsHeart failure (NYHA class III or IV)Left ventricular ejection fraction less than 35%Recurrent vaso-vagal syncopal episodesUnilateral or bilateral vagotomyHemodynamic instabilityStructural heart damageImplanted active electrical medical device, such as pacemaker, implantable loop recorders, defibrillator, or deep brain stimulatorImplanted metal or electrical devices in the head or treated handNot currently on anticoagulantsHistory of epilepsy or seizuresPeripheral neuropathy affecting the upper left extremityPregnancy, anticipated pregnancy, or nursing during the studyUnable or unwilling to comply fully with study procedures and followup, including atrial fibrillation diary requirementsKnown allergy to any of the device materials that are in contact with prospective subject's skinCurrent participation, or previous participation within the last 30 days, in another interventional clinical trial that may confound the results of this study, unless otherwise approved by the SponsorSubjects unable to communicate with the Investigator and study staffPresence of any health condition that should preclude participation in this study, per the Investigator's opinion