tVNS Device for Atrial Fibrillation

Overseen By Natalia Wells-Serrano

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Sick sinus syndrome, AV block, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

160 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if tVNS, which sends electrical pulses to the vagus nerve, can help patients with irregular heartbeats by regulating their heart rhythms. Vagus nerve stimulation has shown promise for managing heart rhythm issues.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the tVNS treatment for atrial fibrillation?

The research on low-voltage electrical stimulation shows promising results in terminating irregular heart rhythms like atrial fibrillation, suggesting that similar approaches, such as tVNS, might be effective. ^{1 2 3 4 5}

How is the tVNS treatment for atrial fibrillation different from other treatments?

The tVNS treatment for atrial fibrillation is unique because it is a non-invasive method that uses electrical stimulation of the vagus nerve through the skin at the tragus (a part of the ear) to help regulate heart rhythm. Unlike traditional drug therapies, it aims to balance the nervous system's influence on the heart without the need for medication. ^{6 7 8 9 10}

Research Team

Stavros Stavrakis, MD

Principal Investigator

University of Oklahoma

Eligibility Criteria

This trial is for individuals with paroxysmal atrial fibrillation, which means their heart occasionally beats irregularly. It's not for those with significant heart valve issues, severe kidney disease on dialysis, pregnant women, certain types of heart block without a pacemaker, history of vagotomy or frequent fainting spells due to vasovagal syncope, very weak hearts (ejection fraction <40%), or recent stroke or serious heart events.

Inclusion Criteria

I have episodes of irregular heartbeat.

I have episodes of irregular heartbeat.

Exclusion Criteria

I am on dialysis for end-stage kidney disease.

I have a serious heart valve problem.

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Optimization Phase

Patients with paroxysmal AF are randomized to a series of stimulation frequencies and intensities to define optimal effects and 'dosing' of tVNS.

5 minutes per session

Multiple sessions (in-person)

Treatment

Patients with paroxysmal AF not undergoing ablation are randomized to active or sham tVNS for 6 months using optimal parameters.

6 months

Daily sessions (self-administered)

Follow-up

Participants are monitored for safety and effectiveness after treatment using continuous monitoring with a smartwatch.

6 months

Treatment Details

Interventions

• Transcutaneous Electrical Nerve Stimulation Device

Trial Overview The study tests if tVNS—a non-invasive nerve stimulation—can improve the condition and reduce episodes over six months compared to fake (sham) treatment. Researchers will also look for physical and biochemical signs that show who benefits most from this therapy.

Participant Groups

Group I: Active TENS Stimulation Active Control 1 Intervention

Group II: Inactive TENS Stimulation Placebo Group 1 Intervention

Transcutaneous Electrical Nerve Stimulation Device is already approved in United States, European Union for the following indications:

Approved in United States as Transcutaneous Vagal Stimulation for:

• Paroxysmal atrial fibrillation

Approved in European Union as Transcutaneous Vagal Stimulation for:

• Not specified in provided sources

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Findings from Research

In a study of 199 horses undergoing transvenous electrical cardioversion (TVEC) for atrial fibrillation, the procedure had a high success rate of 94.4%, with mitral regurgitation and AF cycle length identified as key factors influencing success.

The study also found a recurrence rate of 31.9%, with significant risk factors for recurrence including being a stallion, having mitral regurgitation, and longer duration of atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transvenous electrical cardioversion of atrial fibrillation in horses: Horse and procedural factors correlated with success and recurrence. Vernemmen, I., Van Steenkiste, G., Dufourni, A., et al.[2022]

Transvenous electrical cardioversion (TVEC) is a promising alternative to quinidine salts for treating atrial fibrillation in horses, offering higher efficacy at lower energy levels.

The report provides detailed guidance on the TVEC technique, including potential complications and illustrated examples, making it a valuable resource for veterinarians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to perform transvenous electrical cardioversion in horses with atrial fibrillation. McGurrin, MK., Physick-Sheard, PW., Kenney, DG.[2008]

Transvenous electrical cardioversion (TVEC) is highly effective for treating atrial fibrillation in horses, achieving successful cardioversion in 71 out of 72 episodes with a mean energy of 165.43 J.

Factors such as age and sex influence the energy required for successful cardioversion, but the duration of arrhythmia prior to treatment does not affect the treatment outcome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transvenous electrical cardioversion of equine atrial fibrillation: patient factors and clinical results in 72 treatment episodes. McGurrin, MK., Physick-Sheard, PW., Kenney, DG.[2016]

The transvenous transseptal (TS) approach for transcatheter aortic valve replacement (TAVR) was successfully performed in 9 inoperable patients with significant contraindications for other access methods, demonstrating its feasibility as an option for patients with limited access.

At 6 months post-procedure, patients showed significant improvement in heart function (NYHA Class improved from 3.4 to 1.7) with no major complications such as cerebrovascular events or rehospitalizations, although some experienced major bleeding and acute kidney injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transseptal antegrade transcatheter aortic valve replacement for patients with no other access approach - a contemporary experience. Cohen, MG., Singh, V., Martinez, CA., et al.[2014]

A novel 2-stage low-voltage defibrillation protocol was developed, which first converts ventricular fibrillation (VF) into ventricular tachycardia (VT) using low-voltage stimuli, and then terminates VT, requiring significantly less energy than traditional methods.

The study demonstrated that applying low-voltage stimuli at specific rates (88% of the VF cycle length) effectively defibrillated VF, using only 0.58% of the energy needed for a single strong biphasic shock, highlighting a potential for safer and more efficient defibrillation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Terminating ventricular tachyarrhythmias using far-field low-voltage stimuli: mechanisms and delivery protocols. Rantner, LJ., Tice, BM., Trayanova, NA.[2022]

Transcutaneous vagus nerve stimulation (tVNS) was found to significantly increase salivary alpha amylase (SAA) levels and reduce the decline of salivary cortisol in healthy participants, indicating a modulation of hormonal indices related to noradrenergic function.

However, tVNS did not show any significant effects on psychophysiological measures such as P3 amplitude or pupil size, suggesting that while it may influence hormonal responses, it does not impact certain cognitive or physiological indices in the same way.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The neuromodulatory and hormonal effects of transcutaneous vagus nerve stimulation as evidenced by salivary alpha amylase, salivary cortisol, pupil diameter, and the P3 event-related potential. Warren, CM., Tona, KD., Ouwerkerk, L., et al.[2019]

In a study involving 10 patients undergoing coronary artery bypass grafting, low-level vagus nerve stimulation through the tragus (tLLVNS) significantly increased unipolar potential voltage, indicating enhanced atrial electrophysiological properties.

Some patients experienced additional benefits during tLLVNS, such as reduced total activation time and changes in sinoatrial node exit sites, suggesting potential antiarrhythmic effects that could help in preventing atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insights Into the Effects of Low-Level Vagus Nerve Stimulation on Atrial Electrophysiology: Towards Patient-Tailored Cardiac Neuromodulation. Kharbanda, RK., Ramdat Misier, NL., van Schie, MS., et al.[2023]

Low-level tragus stimulation (LLTS) is a promising non-invasive treatment that has shown potential benefits in managing various cardiovascular conditions, including atrial fibrillation (AF) and heart failure with preserved ejection fraction (HFpEF).

Preliminary clinical studies suggest that LLTS may improve heart function and reduce arrhythmias by positively influencing the balance between the sympathetic and parasympathetic nervous systems, although further research and larger trials are needed to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive Low-level Tragus Stimulation in Cardiovascular Diseases. Jiang, Y., Po, SS., Amil, F., et al.[2020]

Transcutaneous low-level vagus nerve stimulation (tVNS) in 15 male volunteers showed significant reductions in left ventricular contractility and output, indicating a potential for cardiac autonomic modulation.

While tVNS reduced heart workload, it also led to increased blood pressure and total peripheral resistance, suggesting a reflex response that needs further investigation to understand its therapeutic implications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular responses to low-level transcutaneous vagus nerve stimulation. Sinkovec, M., Trobec, R., Meglic, B.[2021]

Transcutaneous vagus nerve stimulation (tVNS) significantly reduced postural tachycardia in patients with POTS, showing a mean heart rate increase of 17.6 beats/min in the active group compared to 31.7 beats/min in the sham group after 2 months.

tVNS also led to lower levels of antiadrenergic autoantibodies and inflammatory cytokines, along with improved heart rate variability, indicating its potential as a safe and effective noninvasive treatment for POTS without any reported side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive Vagus Nerve Stimulation in Postural Tachycardia Syndrome: A Randomized Clinical Trial. Stavrakis, S., Chakraborty, P., Farhat, K., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Transvenous electrical cardioversion of atrial fibrillation in horses: Horse and procedural factors correlated with success and recurrence. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

How to perform transvenous electrical cardioversion in horses with atrial fibrillation. [2008]

3. United States pubmed.ncbi.nlm.nih.gov

Transvenous electrical cardioversion of equine atrial fibrillation: patient factors and clinical results in 72 treatment episodes. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Transseptal antegrade transcatheter aortic valve replacement for patients with no other access approach - a contemporary experience. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Terminating ventricular tachyarrhythmias using far-field low-voltage stimuli: mechanisms and delivery protocols. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The neuromodulatory and hormonal effects of transcutaneous vagus nerve stimulation as evidenced by salivary alpha amylase, salivary cortisol, pupil diameter, and the P3 event-related potential. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Insights Into the Effects of Low-Level Vagus Nerve Stimulation on Atrial Electrophysiology: Towards Patient-Tailored Cardiac Neuromodulation. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Non-invasive Low-level Tragus Stimulation in Cardiovascular Diseases. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Cardiovascular responses to low-level transcutaneous vagus nerve stimulation. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Noninvasive Vagus Nerve Stimulation in Postural Tachycardia Syndrome: A Randomized Clinical Trial. [2023]