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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 belowSelect...
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
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
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.
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.
Find a Location
Who is running the clinical trial?
University of OklahomaLead Sponsor
473 Previous Clinical Trials
93,591 Total Patients Enrolled
13 Trials studying Atrial Fibrillation
2,518 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 21 years old.I am having emergency open heart surgery.I am scheduled for open heart surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Active stimulation
- Group 2: Sham stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.