Using Electrical Nerve Stimulation to Control Atrial Fibrillation

Inclusion Criteria

• 18 to 75 years of age
• Symptomatic Paroxysmal AF.
• Symptomatic paroxysmal AF is defined by AF with patient-reported perception of one or more of the following symptoms: palpitations, dizziness/presyncope, syncope, dyspnea, chest pain, malaise, and fatigue and activity intolerance.
• There is at least one ECG-documented AF episode.
• Unresponsive to conventional therapy is defined by not responding to at least 1 antiarrhythmic drug (class I, class III, or atrioventricular nodal blocker).
• The left atrial size 30 seconds in duration with an atrial fibrillation burden determined by a minimum of 7 days of continuous ePatch monitoring within 6 months before surgery.

Exclusion Criteria

• Patients without AF episodes during monitoring period will be excluded from the study and count as screen failure
• Left ventricular ejection fraction 30 s in duration or (2) < 30 s in duration, but is associated with hemodynamic consequences such as hypotension and syncope.
• Patients with a vagal nerve stimulator
• Active thyrotoxicosis
• Sick sinus syndrome with symptomatic bradycardia
• Heart rate < 50 beats per minute in sinus rhythm on 12-lead ECG
• Systolic blood pressure < 90 mm Hg
• Any experimental medication concomitantly or within 4 weeks of participation in the study
• Subjects with cardiac implantable electronic device (CIED) such as pacemakers and implantable cardioverter-defibrillators (ICDs)
• Pre-existing neuromodulation devices, such as vagal nerve stimulators, spinal cord stimulators and sacral nerve stimulators
• People with a history of allergy to ECG electrodes, adhesive tape, or nylon
• Pregnant women