Cardiac Output Autonomic Stimulation Therapy for Heart Failure - Hemodynamic Effects

Study Overview
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Brief Summary
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A single-arm study to observe NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System hemodynamic and other physiologic effects.

Official Title
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Cardiac Output Autonomic Stimulation Therapy for Heart Failure - Hemodynamic Effects

Conditions
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Heart Failure Acute, Heart Failure

Intervention / Treatment
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* Device: NeuroTronik CANS Therapy® System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal sinus rhythm by ECG Men and women 21-75 years old Patients with stable symptomatic heart failure, New York Heart Association (NYHA) class II, III, or IV. Exclusion Criteria: Systolic Blood Pressure < 90 mmHg or > 160 mmHg Current amiodarone therapy or any other antiarrhythmic therapy Coronary artery bypass graft surgery or percutaneous coronary intervention within prior 1 month Enzyme-positive MI within prior 1 month Patients who have been hospitalized for heart failure and who required the use of HF IV therapy within 30 days before enrollment (measured from release) History of recent severe ventricular arrhythmias Pre-existing carotid artery or cerebral disease Patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis) Patients with prior vagalotomy Patients with current or prior vagal nerve stimulators Subjects with narrow angle glaucoma Renal failure - on dialysis or serum creatinine > 2.0 mg/dl Hepatic failure - bilirubin, SGOT, or SGPT > 4X upper limit of normal Patients with a life expectance < 12 months per physician judgment Women who are pregnant Allergy to fentanyl, midazolam, propofol, eggs, egg products, soybeans, or soy products Subjects unwilling or unable to provide consent for the protocol

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeuroTronik CANS Therapy® System<br> | Device: NeuroTronik CANS Therapy® System<br>* The NeuroTronik CANS Therapy® System is a percutaneous, catheter-based, bedside electrical stimulation system. The System consists of the single-use, disposable NeuroCatheter™ and NeuroCatheter™ Placement Kit, along with the reusable, bedside NeuroModulator™ Development System, and the NeuroTronik CANS Therapy™ Cable.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular pressure and volume |  | One hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate |  | One hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrical Stimulation Therapy; Electrodes; Parasympathetic Nervous System; Sympathetic Fibers, Post Ganglionic; Congestive Heart Failure; Heart Failure