A single-arm study to observe NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System hemodynamic and other physiologic effects.
Who can participate
Age range21 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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