Peripheral Nerve Stimulation Therapy for Atrial Fibrillation

• Wrist Device (Device): peripheral nerve stimulation via wrist-worn device
• Ear Device (Device): peripheral nerve stimulation via ear-worn device
• Sham Device (Device): Wrist-worn device that does not actually deliver stimulation

Primary outcomes

• Percentage of time spent in AF during the treatment period compared to the run-in period (prior to treatment) for AF episodes >= 30 seconds duration [8 weeks]

Secondary outcomes

• Time to first recurrence of any AF (>= 30 seconds duration) during treatment period compared to run-in period [8 weeks]
• Time to first recurrence of symptomatic AF during treatment period compared to run-in period [8 weeks]
• Average AF episode duration during the treatment period compared to the run-in period (for episodes >= 30seconds duration) [8 weeks]
• Number of AF episodes lasting >= 5.5 hours [8 weeks]
• Average duration of ongoing AF episodes (>= 30 seconds duration) following the start of therapy sessions [8 weeks]
• Atrial Fibrillation Effect on Quality of Life (AFEQL) score at the end of the treatment period compared to end of the run-in period [8 weeks]
• Compliance to per-protocol therapy measured by the percentage of full and partial therapy sessions delivered relative to total sessions required per-protocol [8 weeks]
• Compliance of daily therapy measured by the percentage of treatment days subjects performed full or partial therapy sessions [8 weeks]

Other outcomes

• Number of AF-related emergency visits [8 weeks]
• Number of AF-related in-patient hospitalizations [8 weeks]
• Number of cardioversion procedures [8 weeks]

Sex: All, ages: 22 Years to 85 Years

Inclusion Criteria:

* At least 22 years of age and up to 85 years of age
* Diagnosed 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 two symptomatic or asymptomatic atrial fibrillation episodes over the last month, or at least one symptomatic or asymptomatic atrial fibrillation episode in the last two weeks
* On anticoagulants if indicated by treatment guidelines
* Willing to stay on stable medications for the duration of the study
* Competent and willing to provide written, informed consent to participate in the study

Exclusion Criteria:

* Cardiac ablation within the last 6 months, or cardiac ablation planned within 8 weeks of Visit 1
* Cardioversion procedure performed within the last 12 weeks
* Valvular atrial fibrillation by transthoracic echocardiography
* Abnormal left atrial enlargement, as measured by left atrial anteroposterior diameter greater than 5.5 cm or left atrial volume index greater than 48 mL/m2
* Prior or planned cardiac transplantation or cardiac surgery
* Cerebral ischemic event (stroke or transient ischemic attack) within the last 6 months
* Myocardial infarction within the last 6 months
* Heart failure (NYHA class III or IV)
* Left ventricular ejection fraction less than 35%
* Recurrent vaso-vagal syncopal episodes
* Unilateral or bilateral vagotomy
* Hemodynamic instability
* Structural heart damage
* Implanted active electrical medical device, such as pacemaker, implantable loop recorders, defibrillator, or deep brain stimulator
* Implanted metal or electrical devices in the head or treated hand
* History of epilepsy or seizures
* Peripheral neuropathy affecting the upper left extremity
* Pregnancy, anticipated pregnancy, or nursing during the study
* Unable or unwilling to comply fully with study procedures and followup, including atrial fibrillation diary requirements
* Known allergy to any of the device materials that are in contact with prospective subject's skin
* Current 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 Sponsor
* Subjects unable to communicate with the Investigator and study staff
* Presence of any health condition that should preclude participation in this study, per the Investigator's opinion