Optimizing Vagal Stimulation for Atrial Fibrillation
Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF)
This study is testing if a new way of stimulating a nerve can help people with occasional heart rhythm problems feel better and reduce their symptoms over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 21 Years to 90 Years |
| Sex | All |
| Sponsor | University of Oklahoma Academic / other |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT05172765 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcutaneous vagal nerve stimulation (tVNS) on patients with paroxysmal atrial fibrillation (AF). It aims to determine the optimal stimulation parameters and their impact on autonomic tone and AF burden over a six-month period, comparing active stimulation to sham stimulation. The study will also identify physiological and biochemical markers that indicate a response to chronic tVNS. Patients will be randomized to different stimulation frequencies and intensities to find the most effective treatment approach.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with paroxysmal atrial fibrillation.
Not a fit: Patients with conditions such as sick sinus syndrome, significant heart block, or severe heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the burden of paroxysmal atrial fibrillation for patients.
How similar studies have performed: While the specific approach of tVNS for atrial fibrillation is novel, similar neuromodulation techniques have shown promise in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Oklahoma City, Oklahoma
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (Recruiting)
Study contacts
- Principal investigator: Stavros Stavrakis, MD — University of Oklahoma
- Study coordinator: Natalia Wells-Serrano
- Email: Natalia-WellsSerrano@ouhsc.edu
- Phone: 405-271-4742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.