What side effects are associated with this type of intervention?

Transcutaneous Vagus Nerve Stimulation (tVNS) is a non-invasive treatment for atrial fibrillation that aims to reduce inflammation and increase the atrial refractory period. Common side effects of tVNS include mild device-associated adverse events such as a warm sensation, numbness in the arm or hand, redness, itching, tingling, muscle spasm, arm pain, shoulder pain, and neck pain. These side effects are generally mild and transient, with no serious adverse events reported.

What prior FDA approvals exist?

The FDA has approved various treatments for Atrial Fibrillation (AF), including antiarrhythmic drugs like amiodarone and ibutilide, which are used to restore normal heart rhythm. While tVNS is a non-invasive therapy under investigation for its potential to reduce inflammation and increase atrial refractory period, similar neuromodulation techniques like Vagus Nerve Stimulation (VNS) have been explored for their effects on the autonomic nervous system in AF management. However, specific FDA approvals for tVNS in AF treatment are not yet established.

What other types of research exist?

Promising novel alternatives to tVNS for Atrial Fibrillation patients include: 1) Low-level Vagus Nerve Stimulation (LL-VNS), which has shown potential in reducing sympathetic outflow and atrial tachyarrhythmias. 2) Subcutaneous Nerve Stimulation (ScNS), which has demonstrated efficacy in reducing ventricular rate and stellate ganglion nerve activity, potentially improving cardiac function. These alternatives offer non-invasive or minimally invasive options that may help manage AF by modulating autonomic nervous system activity.

← Back to Search

Behavioural Intervention

tVNS for Atrial Fibrillation (STOP_AF Trial)

N/A

Recruiting

Led By Stavros Stavrakis, MD, PhD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years.

Patients scheduled to undergo coronary artery bypass surgery, major vascular/aneurysm repair requiring bypass, valvular replacement or repair, or both, for clinically indicated reasons.

Must not have

Recurrent vasovagal syncope

Known channelopathy such as Brugada syndrome, long QT syndrome, or Catecholaminergic monomorphic ventricular tachycardia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 12 hours of arrival to the icu after surgery and on postop day 3 (2 days)

Summary

This trial tests if using electrical pulses on a nerve in the ear can prevent irregular heartbeats in patients after heart surgery. The treatment aims to reduce inflammation and help the heart beat regularly.

Who is the study for?

This trial is for adults over 18 who are scheduled for cardiac surgery and currently have a normal heart rhythm. They must be willing to follow the study procedures. People with certain heart conditions, pregnant women, those on chronic amiodarone therapy or with complex congenital heart disease, among others, cannot participate.

What is being tested?

The trial is testing if non-invasive transcutaneous vagal nerve stimulation (tVNS) can reduce the occurrence of atrial fibrillation after cardiac surgery and shorten hospital stays. Participants will receive either active tVNS or a sham (fake) treatment as a comparison.

What are the potential side effects?

While specific side effects of tVNS are not detailed here, similar treatments may cause local discomfort at the site of stimulation, headache, voice changes or hoarseness.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

I am scheduled for major heart or blood vessel surgery.

Exclusion Criteria

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

Select...

I have had multiple fainting spells.

Select...

I have a diagnosed heart rhythm disorder.

Select...

I have ongoing or permanent atrial fibrillation.

Select...

I have a complex heart condition present since birth.

Select...

I have a heart pump or have had a heart or lung transplant.

Select...

I am scheduled for a heart rhythm correction procedure.

Select...

I need urgent surgery.

Select...

I expect to use amiodarone.

Select...

I have a slow heartbeat or sinus node issue without a pacemaker.

Select...

I have had surgery to cut the nerves to my stomach.

Select...

I have been using amiodarone for a long time.

Select...

I am not pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 12 hours of arrival to the icu after surgery and on postop day 3 (2 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 12 hours of arrival to the icu after surgery and on postop day 3 (2 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 12 hours of arrival to the icu after surgery and on postop day 3 (2 days) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Atrial Fibrillation

Secondary study objectives

Days of hospitalization

Duration of post-op atrial fibrillation

Heart rate during atrial fibrillation

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention GroupExperimental Treatment1 Intervention

Active tVNS (Parasym device, Parasym Health, Inc, London, UK) will be performed with a clip attached to ear at 20 Hz, 250ms at a current just below discomfort threshold for one hour twice a day, starting on post-day 0. Stimulation will continue until 5 days post-operatively or discharge.

Group II: Control GroupPlacebo Group1 Intervention

Sham tVNS will be performed by attaching the Parasym device to the ear and setting output to 0. Stimulation will continue until 5 days post-operatively or discharge.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

active tVNS

2019

N/A

~20

0 / 14Eligibility 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 autonomic modulation techniques like transcutaneous vagus nerve stimulation (tVNS), which reduce inflammation and increase the atrial refractory period to stabilize heart rhythm. This is important for AF patients as it can decrease the frequency and severity of AF episodes, reducing the risk of complications such as stroke and heart failure. Other treatments, such as antiarrhythmic drugs, work by modifying ion channel activity to maintain sinus rhythm, while rate control medications manage heart rate without restoring normal rhythm. Understanding these mechanisms allows for personalized treatment, improving patient outcomes and quality of life.

TREAT AF (Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation): A Randomized Clinical Trial.The neural basis of atrial fibrillation.