Cardiac Output Autonomic Stimulation Therapy for Acute Heart Failure (COAST-AHF)

Study Overview
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Brief Summary
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A feasibility study to investigate the safety and performance of the NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System

Detailed Description
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A single-arm, safety study intended to assess safety and system performance, and the feasibility to improve hemodynamics in patients with acute heart failure syndrome using transvenous, cardiac autonomic nerve stimulation (CANS) therapy. In addition, the effects of NeuroTronik CANS Therapy™ on the congestion of patients will be studied. The study proposes that the NeuroTronik CANS Therapy™ System be deployed during the acute heart failure syndrome hospital admission, along with existing standard treatment.

Official Title
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Cardiac Output Autonomic Stimulation Therapy for Acute Heart Failure (COAST-AHF) - System Design Study

Conditions
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Heart Failure Acute

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: Left Ventricular Ejection fraction < 40%, measured in the last year At least two of the following: Pulmonary Capillary Wedge Pressure > 18 mmHg Pulmonary congestion on Chest X-ray Jugular vein distension Pulmonary rales Edema Dyspnea at rest Two (2) emergency room visits or hospital admissions in the past three (3) months, or three (3) emergency room visits or admissions in the past six (6) months requiring intravenous diuretics, ultrafiltration or in-hospital inotropic therapy. With or without evidence of low perfusion Exclusion Criteria: Systolic Blood Pressure < 90 mmHg or > 160 mmHg Catecholamine or inotropic therapy within the previous 48 hours Levosimendan within the previous 72 hours Chronic outpatient catecholamine or inotropic therapy Presence of implanted pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy device Presence of or prior vagal nerve stimulator Coronary artery bypass graft surgery, percutaneous coronary intervention, acute myocardial infarction, or valve replacement within prior 1 month Second or third degree heart block History of atrial or ventricular arrhythmias History of mitral or aortic valve stenosis or regurgitation Hypertrophic obstructive or infiltrative cardiomyopathy Prior vagotomy Prior heart transplant Narrow angle glaucoma Renal failure - either on dialysis or serum creatinine > 2.0 mg/dl Hepatic failure - bilirubin, serum glutamic oxaloacetic transaminase, or serum glutamic pyruvic transaminase > four times upper limit of normal Life expectancy < 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

Ages Eligible for Study
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Minimum Age: 18 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: Single arm, 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 |
| --- | --- | --- |
| Arterial blood pressure |  | 24 hours | 
| Heart Rate |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output |  | 24 hours | 
| Pulmonary capillary wedge pressure |  | 24 hours | 

 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