Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF)

Description

This proposal aims to determine the effects of tVNS on autonomic tone, atrial substrate and neuromodulators in patients with paroxysmal atrial fibrillation (AF), investigate the chronic effects of optimal tVNS on AF burden in patients with paroxysmal AF over a 6-month period, compared with sham stimulation, and identify physiological and biochemical markers of response to chronic tVNS.

Conditions

Paroxysmal Atrial Fibrillation

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Study Overview

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Study Details

Study overview

This proposal aims to determine the effects of tVNS on autonomic tone, atrial substrate and neuromodulators in patients with paroxysmal atrial fibrillation (AF), investigate the chronic effects of optimal tVNS on AF burden in patients with paroxysmal AF over a 6-month period, compared with sham stimulation, and identify physiological and biochemical markers of response to chronic tVNS.

Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF)

Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF)

Condition
Paroxysmal Atrial Fibrillation
Intervention / Treatment

-

Contacts and Locations

Oklahoma City

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States, 73104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Paroxysmal atrial fibrillation
  • 1. Sick sinus syndrome
  • 2. 2nd and 3rd degree AV block (without pacemaker), bifascicular block or prolonged (PR\>300ms) 1st degree AV block
  • 3. History of vagotomy
  • 4. Recurrent vasovagal syncope
  • 5. Left ventricular ejection fraction \< 40%
  • 6. Significant valvular disorder (i.e., prosthetic valve or hemodynamic significant valvular diseases)
  • 7. Recent stroke (\< 3 months)
  • 8. Myocardial infarction or hospitalization for heart failure (\< 3 months)
  • 9. Severe heart failure (NYHA Class IV)
  • 10. End stage kidney disease on dialysis
  • 11. Pregnancy

Ages Eligible for Study

21 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Oklahoma,

Stavros Stavrakis, MD, PRINCIPAL_INVESTIGATOR, University of Oklahoma

Study Record Dates

2026-05-29