Cardiac Output Autonomic Stimulation Therapy for Heart Failure - Hemodynamic Effects (COAST-HF FX)

NeuroTronik

Status

Unknown

Conditions

Heart Failure

Heart Failure Acute

Treatments

Device: NeuroTronik CANS Therapy® System

Study type

Interventional

Funder types

Industry

Identifiers

700003-02

Details and patient eligibility

About

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

Enrollment

30 estimated patients

Sex

All

Ages

21 to 75 years old

Volunteers

No Healthy Volunteers

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