What side effects are associated with this type of intervention?

Common treatments for atrial fibrillation include electrical cardioversion, pharmacologic therapy with drugs like amiodarone and sotalol, and non-invasive neuromodulation techniques such as transcutaneous auricular vagus nerve stimulation (taVNS). Known side effects of these treatments can vary. For electrical cardioversion, side effects may include skin burns and arrhythmias. Pharmacologic therapies can cause side effects like thyroid dysfunction, pulmonary toxicity, and liver damage (amiodarone) or proarrhythmia and bradycardia (sotalol). Neuromodulation techniques like taVNS are generally well-tolerated, but mild side effects such as tingling, lightheadedness, and tinnitus have been reported.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Atrial Fibrillation, including antiarrhythmic agents like flecainide, propafenone, dofetilide, amiodarone, and ibutilide. These drugs are used for pharmacologic cardioversion and rhythm control. In terms of neuromodulation, the FDA has approved devices such as transcranial magnetic stimulation (TMS) for migraine, which may have implications for AF treatment. However, specific FDA approvals for vagus nerve stimulation (VNS) in AF are not detailed in the provided context. The ongoing research into taVNS aims to explore its potential in reducing heart rate in AF patients, indicating a growing interest in neuromodulation therapies for AF.

What other types of research exist?

Promising, novel alternatives to taVNS for atrial fibrillation patients include: 1) Low-Level Vagus Nerve Stimulation (LL-VNS), which has shown efficacy in reducing atrial tachyarrhythmias and sympathetic outflow in canine models. 2) Transvenous Parasympathetic Nerve Stimulation (PNS) in the inferior vena cava, which has demonstrated the ability to control rapid ventricular rates during AF. 3) Remote Electrical Neuromodulation, which has been effective in migraine treatment and may have potential applications in AF management due to its neuromodulatory effects.

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Behavioural Intervention

taVNS for Atrial Fibrillation

N/A

Waitlist Available

Led By Harald M Stauss, MD, PhD

Research Sponsored by Burrell College of Osteopathic Medicine

Eligibility Criteria Checklist

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

Must have

Persistent atrial fibrillation

On anti-coagulation throughout the study

Must not have

Not on anti-coagulation

Below 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after one week of treatment or sham treatment

Summary

This trial is testing if applying a small electrical current to the ear can help lower the heart rate in patients with persistent irregular heartbeats. The treatment works by slowing down the heart's electrical signals. Patients will use this device daily for a short period to see if it makes a difference.

Who is the study for?

This trial is for adults over 18 with persistent atrial fibrillation who are on anticoagulation therapy. It's not suitable for pregnant individuals, those under 18, or anyone with a history of vestibulocochlear nerve issues like hearing loss or epilepsy.

What is being tested?

The study tests if non-invasive ear stimulation (taVNS) can reduce heart rate in patients with persistent atrial fibrillation. Participants will self-administer taVNS daily and have their heart activity monitored to see if there's a difference in heart rate reduction.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, skin irritation from the ECG patch, and possibly mild dizziness or nausea related to vagus nerve stimulation.

Eligibility Criteria

Inclusion Criteria

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

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I have ongoing irregular heartbeats.

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I am taking blood thinners and will continue during the study.

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I am 18 years old or older.

Exclusion Criteria

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

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I am not taking blood thinners.

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I am under 18 years old.

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I have epilepsy or a history of it.

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I have had issues with my hearing or balance due to nerve damage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during 30 minutes of treatment or sham treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during 30 minutes of treatment or sham treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and during 30 minutes of treatment or sham treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Ventricular rate during taVNS application

Weekly ventricular rate

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active InterventionActive Control1 Intervention

Participants will self-administer active taVNS for 30 min per day for 7 days.

Group II: Sham InterventionPlacebo Group1 Intervention

Participants will self-administer sham-taVNS for 30 min per day for 7 days.

0 / 7Eligibility 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 non-pharmacologic interventions. Rate control involves medications like beta blockers and calcium channel blockers to slow the heart rate by blocking signals through the atrioventricular (AV) node. Rhythm control aims to restore normal heart rhythm using antiarrhythmic drugs such as flecainide or amiodarone. Non-pharmacologic treatments, like Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), modulate vagus nerve activity to potentially reduce heart rate and stabilize cardiac function. These treatments are crucial for AF patients as they help manage symptoms, improve quality of life, and reduce the risk of complications such as stroke.

The results of pacing trials for the prevention and termination of atrial tachyarrhythmias: is there any evidence of therapeutic breakthrough?