What side effects are associated with this type of intervention?

Common treatments for atrial fibrillation include medications like beta-blockers and antiarrhythmic drugs, catheter ablation, and devices such as pacemakers. Beta-blockers can cause fatigue, cold extremities, and bradycardia. Antiarrhythmic drugs may lead to dizziness, nausea, and proarrhythmia. Catheter ablation carries risks of bleeding, infection, and cardiac tamponade. Pacemakers can cause infection, lead displacement, and device malfunction. Treatments modulating the autonomic nervous system, like tVNS, may cause mild side effects such as tingling, redness, and muscle spasms, but serious adverse events are rare.

What prior FDA approvals exist?

FDA-approved treatments for atrial fibrillation that modulate the autonomic nervous system include various neuromodulation techniques. While specific FDA approvals for transcutaneous Vagus Nerve Stimulation (tVNS) in AF are not detailed, other neuromodulation methods like Vagus Nerve Stimulation (VNS) have been explored for related conditions. VNS has shown efficacy in reducing seizure frequency in epilepsy and has been studied for its potential benefits in treatment-resistant depression. These neuromodulation techniques aim to influence autonomic tone, which is relevant to the management of AF.

What other types of research exist?

Promising novel alternatives to tVNS for AF patients include low-level vagus nerve stimulation (LLVNS), which has shown potential in reducing atrial tachyarrhythmias and cardiac remodeling in animal models. Additionally, advancements in pharmacologic cardioversion with drugs like amiodarone, ibutilide, and flecainide, as well as repeated electrical cardioversion, are also noteworthy. These options offer different mechanisms to manage AF and may be considered based on individual patient profiles.

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Neuromodulation Device

tVNS Device for Atrial Fibrillation

Q: What is the mechanism of action of this treatment?

Common treatments for Atrial Fibrillation (AF) include rate control, rhythm control, and anticoagulation. Rate control medications, such as beta-blockers and calcium channel blockers, slow the heart rate by inhibiting the atrioventricular (AV) node. Rhythm control strategies, including antiarrhythmic drugs and cardioversion, aim to restore and maintain normal sinus rhythm. Anticoagulation therapy, using drugs like warfarin or direct oral anticoagulants, prevents thromboembolism, a major risk in AF patients. Treatments like transcutaneous Vagus Nerve Stimulation (tVNS) modulate the autonomic nervous system, potentially reducing AF episodes by enhancing parasympathetic activity and stabilizing heart rhythms. These mechanisms are crucial as they help manage symptoms, reduce stroke risk, and improve the quality of life for AF patients.

N/A

Recruiting

Led By Stavros Stavrakis, MD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Paroxysmal atrial fibrillation

Must not have

Sick sinus syndrome

History of vagotomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, transcutaneous electrical nerve stimulation devices like tVNS can sometimes cause skin irritation where they're applied and may lead to discomfort or tingling sensations during use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have episodes of irregular heartbeat.

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I have episodes of irregular heartbeat.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with sick sinus syndrome.

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I have had surgery to remove part of my vagus nerve.

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I frequently faint due to sudden drops in my heart rate and blood pressure.

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I have a serious heart valve problem.

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I have severe heart failure.

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I am on dialysis for end-stage kidney disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effects of tVNS on Atrial fibrillation burden

Secondary study objectives

Effects of tVNS on Autonomic Tone

Effects of tVNS on P wave alternans

Effects of tVNS on neuropeptide Y

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active TENS StimulationActive Control1 Intervention

Group II: Inactive TENS StimulationPlacebo Group1 Intervention

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Atrial Fibrillation (AF) include rate control, rhythm control, and anticoagulation. Rate control medications, such as beta-blockers and calcium channel blockers, slow the heart rate by inhibiting the atrioventricular (AV) node. Rhythm control strategies, including antiarrhythmic drugs and cardioversion, aim to restore and maintain normal sinus rhythm. Anticoagulation therapy, using drugs like warfarin or direct oral anticoagulants, prevents thromboembolism, a major risk in AF patients. Treatments like transcutaneous Vagus Nerve Stimulation (tVNS) modulate the autonomic nervous system, potentially reducing AF episodes by enhancing parasympathetic activity and stabilizing heart rhythms. These mechanisms are crucial as they help manage symptoms, reduce stroke risk, and improve the quality of life for AF patients.

Neuromodulation for the Treatment of Heart Rhythm Disorders.