Peripheral Nerve Stimulation Therapy For Atrial Fibrillation

Overview

About this study

The purpose of this study is to determine and compare the safety and efficacy of transcutaneous afferent patterned stimulation (TAPS) and respiratory-gated auricular vagal afferent nerve stimulation (RAVANS) therapies for the reduction of paroxysmal atrial fibrillation (AF) burden.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • At least 22 years of age and less than 80 years of age.
  • Entering study on normal sinus rhythm.
  • 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  3 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 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 10/17/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Abhishek Deshmukh, M.B.B.S.

Closed for enrollment

Contact information:

CVRU Heart Rhythm Services Research Team

(507) 255-0774

More information

Publications

Publications are currently not available