Actively Recruiting
Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF)
Led by University of Oklahoma · Updated on 2024-03-06
160
Participants Needed
1
Research Sites
193 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
1. Paroxysmal atrial fibrillation
You will not qualify if you...
- Sick sinus syndrome
- 2nd and 3rd degree AV block (without pacemaker), bifascicular block or prolonged (PR>300ms) 1st degree AV block
- History of vagotomy
- Recurrent vasovagal syncope
- Left ventricular ejection fraction < 40%
- Significant valvular disorder (i.e., prosthetic valve or hemodynamic significant valvular diseases)
- Recent stroke (< 3 months)
- Myocardial infarction or hospitalization for heart failure (< 3 months)
- Severe heart failure (NYHA Class IV)
- End stage kidney disease on dialysis
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
Research Team
N
Natalia Wells-Serrano
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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