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CLINICAL RESEARCH

CARDIOVASCULAR CLINICAL RESEARCH TRIALS

(Open Enrollment Only)

Atrial Fibrillation Studies:

Synaptic Plasticity in the Epicardial Ganglionated Plexi (SNAP-GP)

This study will examine changes in synaptic density of ganglionated plexi (GP) neurons in patients with paroxysmal atrial fibrillation (AF) and persistent AF, compared to those without AF who are undergoing planned, cardiac surgery. In addition, the study will examine the effect of low-level tragus stimulation (LLTS) on the synaptic plasticity of the GP neurons.

Physician:  Stavros Stavrakis, MD, PhD
Coordinator:  Karrie Meeks, 405-271-8001, #1, 37520

The Effect of Different Low-Level Tragus Stimulation Parameters on Autonomic Nervous System Function (open to enrollment)

This study aims to study the effect of different tragus stimulation parameters on heart rate variability in healthy volunteers and patients with atrial fibrillation and/or heart failure.

Physician:  Stavros Stavrakis, MD, PhD
Coordinator:  Karrie Meeks, 405-271-8001, #1, 37520

Transcutaneous (Tragus) Vagal Nerve Stimulation for Post-op Afib (open to enrollment)

The purpose of this study is to determine the value of transcutaneous vagus nerve stimulation in reducing the burden of post-operative atrial fibrillation and days of hospitalization after cardiac surgery.

Physician:  Stavros Stavrakis, MD, PhD
Coordinator:  Karrie Meeks, 405-271-8001, #1, 37520

Cardiac Implantable Electronic Devices:

PSR/Micra AV Post Approval Study (Open to enrollment).

Product Surveillance Registry Base Platform Protocol for patients with placement of Micra Pacemakers.

Physician:  Dwight Reynolds, MD
Coordinator:  Michael Stout, 271-9060

Heart Failure Studies:

TECO-HF (Open to enrollment)

Effect of Chronic Low-Level Transcutaneous Vagal Stimulation (TVS) on Endothelial Function, Cognitive Dysfunction and Biomarkers of Vascular Function Oxidative Stress and Inflammation in Patients with Heart Failure with Reduced Ejection Fraction: A Randomized Clinical Trial.

Physician:  Tarun Dasari, MD
Coordinator:  Michael Stout, 271-9060

Magnesphere for HF(Open to enrollment)

Effects on autonomic nervous system through utilization of an electromagnetic resonator in heart failure.

Physician:  Tarun Dasari, MD
Coordinator:  Michael Stout, 271-9060

LLTS in ADHF (Open to enrollment)

Low Level Tragus Stimulation (LLTS) to Modulate Inflammation in Acute Decompensated Heart Failure.

The purpose of this study is to study the effects of non-invasive low-level Tragus Stimulation on inflammation in patients with acute heart failure.

Physician:  Tarun Dasari, MD
Coordinator:  Michael Stout, 271-9060

HRV-HF (Open to enrollment)

The Association Between Autonomic Function Improvement and Heart Failure Treatment Responding: A Cross-Sectional Study

The purpose of this study is to compare the percentage of autonomic improvement in treatment responders and non-responders of heart failure with reduced ejection fraction (HFrEF) patient’s dysfunction.

Physician:  Tarun Dasari, MD
Coordinator:  Michael Stout, 271-9060

The Effect of Low LEVel TrAgus STimulation on the Electrophysiological Substrate of Subjects with Ischemic CardioMyopathy and Heart Failure (ELEVATE)

This study will examine the effect of low-level tragus stimulation (LLTS) on repolarization alternans (RA) in patients with ischemic cardiomyopathy and heart failure. In addition, the study will examine whether this effect is independent of heart rate.

Physician:  Stavros Stavrakis, MD, PhD
Coordinator:  Karrie Meeks, 405-271-8001, #1, 37520

Neuromodulation of Inflammation to Treat Heart Failure with Preserved Ejection Fraction (TIN HF)

This study will examine the effects of LLTS on diastolic dysfunction, exercise capacity and inflammation in patients with HFpEF and determine whether these effects are mediated by suppression of inflammation.

Physician:  Stavros Stavrakis, MD, PhD
Coordinator:   Brittany Karfonta, 405-271-3480

Peripheral Vascular Studies:

BEST REGISTRY (Open to enrollment).

The purpose of this study is to collect information about patients with critical limb ischemia from medical records and from interviews and questionnaires.

Physician:  Beau Hawkins, MD
Coordinator:  Christina Urban, 271-9060

LLTS in Peripheral Arterial Disease (Open to enrollment).

Effect of Low-Level Transcutaneous Vagal Stimulation (TVS) on Endothelial Function, Arterial Stiffness and Biomarkers of Endothelial Function in Patients with Peripheral Arterial Disease.

The purpose of this study is to study the effects of non-invasive low-level Tragus Stimulation on inflammation in patients with Peripheral Arterial Disease.

 Physician:  Tarun Dasari, MD
Coordinator:  Michael Stout, 271-9060

Sepsis:

Nerina Sepsis (SEPSIS)

Transcutaneous Vagus Nerve Stimulation to Regulate Inflammation and Autonomic Imbalance in Sepsis:A Randomized Pilot Trial.

Physician:  Zain Asad, MD
Coordinator:  Michael Stout, 271-9060