Using Electrical Nerve Stimulation to Control Atrial Fibrillation
Using Electrical Nerve Stimulation to Control Atrial Fibrillation
The purpose of this study is to examine if sending mild electrical signals just under your
 skin will improve atrial fibrillation symptoms by controlling your heart rate.
Patients will have a 1:1 randomization to receive subcutaneous electrical nerve stimulation
 (ScNS) to observe if the stimulation can reduce atrial fibrillation burden in patients with
 symptomatic atrial fibrillation (AF). All subjects will undergo the implant of a
 neurostimulator lead. The experimental group will receive stimulation and the control group
 will not receive stimulation. All subjects will complete the same follow up visits to compare
 the 2 groups.

 Primary Objective: To test the hypothesis that chronic subcutaneous nerve stimulation can
 reduce AF burden in patients with severe symptomatic AF unresponsive to conventional
 therapies

 The secondary objective:

 To test the hypotheses that the effect of ScNS on the following endpoints is different
 between the two randomization groups:

 1. Time-dependent reduction of AF burden

 2. Effects of ScNS on ventricular rate control during AF

 3. Reduction of SKNA

 4. Improvement of quality of life

 The study will enroll patients with symptomatic atrial fibrillation unresponsive to
 conventional therapy defined by not responding to at least 1 antiarrhythmic drug. The study
 will enroll 30 patients, including 15 men and 15 women between the 18 and 75 years old. There
 will be no sex/gender/racial/ethnic based exclusion. Patients will be enrolled from the
 Cedars Sinai Medical Center.

 The study will enroll patients with symptomatic atrial fibrillation unresponsive to
 conventional therapy defined by not responding to at least 1 antiarrhythmic drug. The study
 will enroll 30 patients, including 15 men and 15 women between the 18 and 75 years old. There
 will be no sex/gender/racial/ethnic based exclusion. Patients will be enrolled from the
 Cedars Sinai Medical Center.

 The patients will undergo surgical implantation of an externalized lead under the skin on the
 chest wall. The wire is then connected to a neurostimulator. The experimental group (Group A)
 will receive ScNS (3.5 mA) for two weeks. The shame group (Group B) will receive sham (0 mA)
 stimulation for two weeks. The AF burden will be assessed by either a 7- day patch monitor or
 a mobile cardiac telemetry through a skin patch on the chest wall.

 Study duration: 36 Months

 Subject duration: up to 4 months. (7 visits, including the procedure day)
Inclusion Criteria:

 -  18 to 75 years of age

 -  Symptomatic AF.

 -  Symptomatic 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 within 6 months before signing
 the consent.

 -  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 recorded on the eligibility visit 7 day
 continuous rhythm recording

 Exclusion Criteria:

 -  Patients without AF episodes during monitoring period will be excluded from the study
 and count as screen failure

 -  Left ventricular ejection fraction <40%

 -  Heart failure with functional classes III or IV

 -  Recurrent vasovagal syncope

 -  Valvular AF (severe mitral regurgitation, mitral stenosis)

 -  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.

 -  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, nylon or latex

 -  Pregnant women