Using Electrical Nerve Stimulation to Control Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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 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 (3.5mA) for two weeks. The sham group (Group B) will receive sham (0 mA)
      stimulation for two weeks. The AF burden will be assessed by a 7-day mobile cardiac telemetry
      device provided by Preventice. An additional mobile cardiac telemetry device, Bittium Faros,
      will also be worn at similar time points to monitor skin sympathetic nerve activity. An Apple
      watch will be used to collect additional information on the frequencies of AF between the
      Baseline Visit until the 3 Month Visit 7 Day Mobile Cardiac Telemetry is complete. After
      completion of the week 3 visit, the sham group (Group B) will be able to receive ScNS (3.5
      mA) for two weeks. The AF burden will be assessed post-procedure by mobile cardiac telemetry
      by Preventice and Bittium Faros

      Study duration: 36 Months

      Subject duration: up to 5 months.
    

Intervention name(s): Device Implant with Active Treatment; Device Implant without Active Treatment
Intervention type(s): Device; Device
Intervention description(s): ScNS at 3.5mA output for 2 weeks; No device output for 2 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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 comparing the 2 groups. The control group will have an option to cross over to the experimental group 3 weeks post-randomization to receive the stimulation. They will repeat the baseline visit, procedure visit and all follow-up visits post-procedure.
Masking: Single (Participant)
Primary purpose: Treatment