Peripheral Nerve Stimulation Therapy for Atrial Fibrillation
Atrial Fibrillation
About this trial
This is an interventional other trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria: At least 22 years of age and less than 80 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 one symptomatic atrial fibrillation episodes per month over the last three months AF burden of at least 5%, as measured within the past 3 months, with no change in AF treatment since measurement Willing to stay on stable medications for the duration of the study Able and willing to use their smartphone to download the application associated with the Cardiac Measurement Device Competent and willing to provide written, informed consent to participate in the study Exclusion Criteria: Prior cardiac ablation, or cardiac ablation planned within 6 weeks of Visit 1 Cardioversion procedure performed within the last 12 weeks Valvular atrial fibrillation by transthoracic echocardiography Left atrial anteroposterior diameter greater than 5.5 cm by transthoracic echocardiography 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 Not currently on anticoagulants 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
Sites / Locations
- Mayo Clinic
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Sham Comparator
Wrist Device
Ear Device
Sham Device
Twice daily stimulation sessions during the 4-week treatment period
Twice daily stimulation sessions during the 4-week treatment period
Twice daily "stimulation" sessions during the 4-week treatment period