Clinical Trials

Inclusion Criteria:

• At least 22 years of age and up to 85 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 two symptomatic or asymptomatic atrial fibrillation episodes over the last month, or at least one symptomatic or asymptomatic atrial fibrillation episode in the last two weeks.
• On anticoagulants if indicated by treatment guidelines.
• Willing to stay on stable medications for the duration of the study ● 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.
• Abnormal left atrial enlargement, as measured by left atrial anteroposterior diameter greater than 5.5 cm or left atrial volume index greater than 48 mL/m^2.
• 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 follow-up, 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/9/23. Questions regarding updates should be directed to the study team contact.