Cardiac Output Autonomic Stimulation Therapy for Heart Failure (COAST-HF) - Human NeuroCatheter Study

Study Overview
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Brief Summary
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A single-center feasibility study in patients undergoing cardiac catheterization, to investigate the acute hemodynamic effects of transvenous cardiac autonomic nerve stimulation.

Detailed Description
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A single-center feasibility study performed in patients undergoing a planned cardiac catheterization. This study investigated the feasibility of the NeuroTronik CANS Therapy™ System to improve acute hemodynamics. Purpose-built stimulation catheters were percutaneously inserted into an upper venous structure near the heart via right femoral vein and or left subclavian vein access using standard introducers and techniques. Subjects were instrumented with left ventricular and femoral artery catheters for pressure measurement and stimulated for approximately 60 minutes. Baseline hemodynamic measures were collected before stimulation and compared to measured values during stimulation. Following completion of the protocol, all in-dwelling equipment and catheters were removed.

Official Title
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Cardiac Output Autonomic Stimulation Therapy for Heart Failure (COAST-HF) - Human NeuroCatheter Study

Conditions
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Cardiac Output, Low

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: Stable symptomatic heart failure - New York Heart Association Class II or III Normal Sinus Rhythm Exclusion Criteria: Unable to gain arterial or venous access using standard percutaneous techniques New York Heart Association Class IV Patient taking amiodarone or other anti-arrhythmic therapy Patients with implanted pacemaker, ICD, or CRT device Patients who had CABG, PCI or enzyme-positive MI within prior month Patients with pre-existing carotid artery or cerebral disease Patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis) Patients who have been hospitalized for heart failure and who required the use of heart failure IV therapy within 30 days before enrollment (measured from release) Patients with current or prior vagal nerve simulator Patients with renal failure Patients with hepatic failure Patients with narrow angle glaucoma Patients who are pregnant Patients with a life expectancy < 12 months per physician judgment Patients with allergy to fentanyl, midazolam, propofol, eggs, egg products, soybeans, or soy products

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

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm, transvenous cardiac autonomic nerve stimulation<br> | Device: NeuroTronik CANS Therapy System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output |  | One hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial blood pressure |  | One hour | 
| Left ventricular pressure |  | One hour | 
| 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, Parasympathetic Nervous System, Sympathetic Fibers, Post Ganglionic, Congestive Heart Failure, Heart Failure