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 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.

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.

Open for enrollment

Contact information:

CVRU Heart Rhythm Services Research Team

(507) 255-0774

More information

Publications

Publications are currently not available
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CLS-20543763

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