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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 minutes

Awards & highlights

SNAP-GP Trial Summary

This trial will examine changes in synaptic density of neurons in the ganglionated plexus in patients with atrial fibrillation before and after low-level tragus stimulation.

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.Check my eligibility

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.See study design

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.

SNAP-GP Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am scheduled for open heart surgery.

SNAP-GP Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

choline acetyltransferase

synaptophysin

tyrosine hydroxylase

SNAP-GP 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor

455 Previous Clinical Trials

97,520 Total Patients Enrolled

13 Trials studying Atrial Fibrillation

2,588 Patients Enrolled for Atrial Fibrillation

Media Library

Parasym Clinical Trial Eligibility Overview. Trial Name: NCT05034419 — Phase 1

Atrial Fibrillation Research Study Groups: Active stimulation, Sham stimulation

Atrial Fibrillation Clinical Trial 2023: Parasym Highlights & Side Effects. Trial Name: NCT05034419 — Phase 1

Parasym 2023 Treatment Timeline for Medical Study. Trial Name: NCT05034419 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does my profile qualify me to participate in this trial?

"This clinical trial is searching for 90 individuals with atrial fibrillation between the ages 21 to 90. Eligibility criteria include being over 21 years old, male or female, and scheduled for open heart surgery."

Answered by AI

Are there any vacancies available within this medical trial?

"Affirmative. According to details listed on clinicaltrials.gov, this investigation is actively attempting to find volunteers for the trial which began on March 24th 2021 and was updated most recently on August 5th 2022. Ninety individuals are required from 1 medical centre."

Answered by AI

How many individuals have enrolled in this experiment thus far?

"Affirmative. According to clinicaltrials.gov, the trial which was first made available on March 24th 2021 is currently seeking participants. 90 people are required from a single centre in order for the study to reach completion."

Answered by AI

Is the age restriction for this clinical trial limited to those over 25 years of age?

"The age range for inclusion in this trial is from 21 years to 90 years of age."

Answered by AI

What safety precautions should be taken when utilizing Parasym as a treatment option?

"Our team at Power judged Parasym to be of a level 1 safety risk, as the current clinical trial is only in Phase 1. Consequently, there is limited evidence backing both its efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Synaptic Plasticity in the Epicardial Ganglionated Plexi

2021. "Synaptic Plasticity in the Epicardial Ganglionated Plexi". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05034419.

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