Using Electrical Nerve Stimulation to Control Atrial Fibrillation

Prior treatment

• Any experimental medication concomitantly or within 4 weeks of participation in the study

Other illness

• Heart failure with functional classes III or IV
• Congenital heart diseases
• Wolff Parkinson-White Syndrome
• Stroke within the past 6 months
• Any history of myocardial infarction
• Malignancies with a life expectancy of \< 1 year
• A history of ablation procedures to treat left atrial tachyarrhythmias or other serious comorbidity
• Any history of sustained ventricular tachycardia (VT) defined by (1) \> 30 s in duration or (2) \< 30 s in duration, but is associated with hemodynamic consequences such as hypotension and syncope.
• Sick sinus syndrome with symptomatic bradycardia
• Heart rate \< 50 beats per minute in sinus rhythm on 12-lead ECG
• Subjects with cardiac implantable electronic device (CIED) such as pacemakers and implantable cardioverter-defibrillators (ICDs)
• People with a history of allergy to ECG electrodes, adhesive tape, or nylon

Lab values

• Patients without AF episodes during monitoring period will be excluded from the study and count as screen failure
• Left ventricular ejection fraction \<40%

Other

• Recurrent vasovagal syncope
• Valvular AF (severe mitral regurgitation, mitral stenosis)
• Patients with a vagal nerve stimulator
• Active thyrotoxicosis
• Systolic blood pressure \< 90 mm Hg
• Pre-existing neuromodulation devices, such as vagal nerve stimulators, spinal cord stimulators and sacral nerve stimulators
• Pregnant women

• 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 \<50 mm by transthoracic echocardiography documented by eligibility visit echocardiogram
• Documented atrial fibrillation as defined as atrial fibrillation \>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.