Clinical Trials Logo

Clinical Trial Summary

Atrial fibrillation (AF) is the most common arrhythmia and the prevalence increase with age. Autonomic nervous system play a critical role in the initiation and maintenance of AF. The intrinsic cardiac autonomic nervous system includes ganglionated plexus (GP) modulate the level of parasympathetic activity to the heart. Experimental and clinical studies suggest that GP activation plays a significant role in clinical AF in both the initiation of and the maintenance of AF. Synaptic plasticity is defined as the ability of synapses to change their strength of transmission. Plasticity of synaptic connections in the brain is a major focus of neuroscience research, as it is the primary mechanism underpinning learning and memory. Beyond the brain however, plasticity in peripheral neurons is less well understood, particularly in the GP neurons innervating the heart. The ability of these neurons to alter parasympathetic activity suggests that plasticity may indeed occur at the synapses formed on and by GP neurons. Such changes may not only fine-tune autonomic innervation of the heart, but could also be a source of maladaptive plasticity during atrial fibrillation. Low level tragus stimulation (LLTS) has been shown to decrease AF burden among patients with paroxysmal AF. However, the exact mechanism remains unclear. The objective of this study is to examine changes in synaptic density of GP neurons in patients with paroxysmal AF and persistent AF compared to those without AF undergoing cardiac surgery. In addition, we aim to examine the effect of LLTS on the synaptic plasticity of the GP neurons. A group of patients undergoing open heart surgery will be randomized to active LLTS for 30 min (pulse width of 200 μs, amplitude of 20 mA and a pulse frequency of 20 Hz) or no stimulation. Biopsy from GP tissue will be taken immediately after stimulation and histological staining for choline acetyl transferase (ChAT), tyrosine hydroxylase (TH) and synaptophysin will be performed to examine synaptic plasticity. Understanding the effect of LLTS on GP SP will help to determine whether changes in synaptic plasticity can increase or decrease autonomic tone of the heart, and its role in generating the aberrant electrical impulses in the GP around the pulmonary veins that can trigger and drive AF.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05034419
Study type Interventional
Source University of Oklahoma
Contact Stavros Stavrakis
Phone 4052714742
Email [email protected]
Status Recruiting
Phase Phase 1
Start date March 24, 2021
Completion date September 30, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04115735 - His Bundle Recording From Subclavian Vein
Recruiting NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Active, not recruiting NCT04546763 - Study Watch AF Detection At Home
Recruiting NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A
Completed NCT03313167 - Screening for Atrial Fibrillation (AF)-Potential Patients to Increase AF Detection Rate
Active, not recruiting NCT04544397 - Outcomes of Second Generation Laser Balloon Ablation for Atrial Fibrillation
Completed NCT02923414 - Comparison of High Versus Escalating Shocks in Cardioverting Atrial Fibrillation N/A
Recruiting NCT04590898 - Peri-device Leakage Closure After LAAO
Completed NCT03593486 - Low-Level EMF Stimulation for Paroxysmal Atrial Fibrillation N/A
Recruiting NCT04043026 - The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
Recruiting NCT04096547 - Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment
Terminated NCT04076917 - Assessment of the Utility of BIOMONITOR to Identify Atrial Fibrillation (AF) in Ablation Candidates Using Precise AF Detection
Active, not recruiting NCT03259373 - IMplementation of an RCT to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation N/A
Recruiting NCT04037397 - First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Persistent Atrial Fibrillation Treatment (RAAFT-3) Phase 3
Recruiting NCT03503812 - Mitigating the Health Effects of Desert Dust Storms Using Exposure-Reduction Approaches N/A
Recruiting NCT04170894 - Radiofrequency Ablation of Atrial Fibrillation Under Apnea N/A