Heart Failure, Heart Failure Acute
Conditions
Keywords
Electrical Stimulation Therapy; Electrodes; Parasympathetic Nervous System; Sympathetic Fibers, Post Ganglionic; Congestive Heart Failure; Heart Failure
Brief summary
A single-arm study to observe NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System hemodynamic and other physiologic effects.
Interventions
DEVICENeuroTronik CANS Therapy® System
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.
Sponsors
NeuroTronik Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left ventricular pressure and volume | One hour |
Secondary
| Measure | Time frame |
|---|---|
| Heart rate | One hour |
Countries
Paraguay
Contacts
Primary ContactAdrian Ebner, Medical Doctor
Outcome results
None listed