What side effects are associated with this type of intervention?

Common treatments for atrial fibrillation (AF) include pharmacologic therapies, electrical cardioversion, and neuromodulation techniques such as Low Level Tragus Stimulation (LLTS). Pharmacologic treatments can cause side effects like drug intolerance, arrhythmic events, and adverse reactions specific to antiarrhythmic drugs such as amiodarone and sotalol. Electrical cardioversion may lead to complications like skin burns, arrhythmias, and thromboembolic events. Neuromodulation techniques, including LLTS, have shown promise in reducing AF burden with minimal side effects, primarily involving mild discomfort at the stimulation site. Overall, while traditional treatments have notable side effects, neuromodulation techniques like LLTS appear to offer a safer alternative with fewer adverse events.

What prior FDA approvals exist?

The FDA has approved several treatments for Atrial Fibrillation (AF), primarily focusing on pharmacological agents and device-based therapies. Pharmacological treatments include anti-arrhythmic drugs such as amiodarone, sotalol, and dofetilide, which help maintain sinus rhythm. Beta-blockers and calcium channel blockers are also commonly used to control heart rate. In terms of neuromodulation, while specific FDA approvals for treatments like Low Level Tragus Stimulation (LLTS) are not detailed, other neuromodulation devices such as transcutaneous electrical nerve stimulators have shown promise in clinical trials for migraine and other conditions. These devices work by modulating neural activity, which is conceptually similar to LLTS aimed at altering synaptic plasticity in ganglionated plexus neurons to manage AF.

What other types of research exist?

Promising novel alternatives to Low Level Tragus Stimulation (LLTS) for Atrial Fibrillation patients include: 1) Vagus Nerve Stimulation (VNS), which can modulate autonomic tone and reduce AF burden; 2) Transcutaneous Electrical Nerve Stimulation (TENS), which may offer non-invasive modulation of cardiac autonomic activity; 3) Pharmacological agents such as amiodarone, ibutilide, and flecainide for rhythm control; 4) Deep Brain Stimulation (DBS) and Transcranial Magnetic Stimulation (TMS) as emerging neuromodulation therapies with potential benefits in autonomic regulation and AF management.

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Parasym Stimulation for Atrial Fibrillation (SNAP-GP Trial)

Phase 1

Recruiting

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

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

Must have

Patient is going to have open heart surgery.

Be older than 18 years old

Must not have

Patients undergoing emergent open heart surgery.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 minutes

Summary

This trial tests whether mild electrical pulses to the ear can help patients with atrial fibrillation by affecting heart neurons that control rhythm. The study focuses on patients undergoing heart surgery and aims to see if this method can change neuron activity to reduce abnormal heartbeats. This technique has been shown to significantly reduce atrial fibrillation in previous studies.

Who is the study for?

This trial is for men and women over 21 years old who are scheduled for open heart surgery. It's not suitable for those needing emergency heart surgery.

What is being tested?

The study tests if low level tragus stimulation (LLTS) affects nerve connections in the heart, which might influence atrial fibrillation. Participants will be randomly assigned to receive LLTS or no stimulation during their surgery.

What are the potential side effects?

Since this trial involves a non-invasive stimulation technique, side effects may include local discomfort at the stimulation site but significant adverse effects are unlikely.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am scheduled for open heart surgery.

Exclusion Criteria

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

Select...

I am having emergency open heart surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 minutes

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

Treatment Details

Study Objectives

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

Primary study objectives

choline acetyltransferase

synaptophysin

tyrosine hydroxylase

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active stimulationExperimental Treatment1 Intervention

Patients undergoing cardiac surgery will be randomized to active low level tragus stimulation for 30 min (pulse width of 200 μs, amplitude of 20 mA and a pulse frequency of 20 Hz). Stimulation will be provided using the Parasym device.

Group II: Sham stimulationPlacebo Group1 Intervention

Patients undergoing cardiac surgery will be randomized to sham stimulation for 30 min. The Parasym device will be placed on the patient's tragus, but no current will be delivered.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Parasym

2018

N/A

~90

0 / 2Eligibility 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 uses medications like beta-blockers and calcium channel blockers to slow the heart rate, while rhythm control aims to restore normal heart rhythm through electrical cardioversion or antiarrhythmic drugs such as amiodarone. Anticoagulation prevents stroke by reducing blood clot formation. Treatments like Low Level Tragus Stimulation (LLTS) target the autonomic nervous system, specifically modulating synaptic plasticity in ganglionated plexus neurons to reduce AF burden. This matters for AF patients as it offers a non-pharmacologic approach to manage AF, potentially reducing side effects and improving quality of life.

Central sleep apnea and atrial fibrillation: A review on pathophysiological mechanisms and therapeutic implications.Neuromodulation for the Treatment of Heart Rhythm Disorders.Median nerve stimulation prevents atrial electrical remodelling and inflammation in a canine model with rapid atrial pacing.