Cardiac Output Autonomic Stimulation Therapy for Heart Failure – Hemodynamic Effects

Overview

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

Full Title of Study: “Cardiac Output Autonomic Stimulation Therapy for Heart Failure – Hemodynamic Effects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Device Feasibility
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 1, 2019

Interventions

  • Device: NeuroTronik 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.

Arms, Groups and Cohorts

  • Experimental: NeuroTronik CANS Therapy® System

Clinical Trial Outcome Measures

Primary Measures

  • Left ventricular pressure and volume
    • Time Frame: One hour

Secondary Measures

  • Heart rate
    • Time Frame: One hour

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NeuroTronik Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Adrian Ebner, Medical Doctor, 011 595 21 202767, adrian_ebner@yahoo.com

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