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

RECRUITINGN/ASponsored by University of Oklahoma
Actively Recruiting
PhaseN/A
SponsorUniversity of Oklahoma
Started2022-09-14
Est. completion2025-10-31
Eligibility
Age21 Years – 90 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT05172765

Summary

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.

Eligibility

Age: 21 Years – 90 YearsHealthy volunteers accepted
Inclusion Criteria:

1\. Paroxysmal atrial fibrillation

Exclusion Criteria:

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

Conditions2

Heart DiseaseParoxysmal Atrial Fibrillation

Locations1 site

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Stavros Stavrakis, MD405-271-9696Stavros-Stavrakis@ouhsc.edu

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