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

Overview

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

Full Title of Study: “Cardiac Output Autonomic Stimulation Therapy for Heart Failure (COAST-HF) – Human NeuroCatheter Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2016

Detailed Description

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.

Interventions

  • Device: NeuroTronik CANS Therapy System

Arms, Groups and Cohorts

  • Experimental: Single arm, transvenous cardiac autonomic nerve stimulation

Clinical Trial Outcome Measures

Primary Measures

  • Cardiac output
    • Time Frame: One hour

Secondary Measures

  • Arterial blood pressure
    • Time Frame: One hour
  • Left ventricular pressure
    • Time Frame: One hour
  • Heart rate
    • Time Frame: One hour

Participating in This Clinical Trial

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

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 Official(s)
    • Adrian Ebner, Medical Doctor, Principal Investigator, Facultad de Ciencias Medicas UNA Paraguay, Asuncion, Paraguay

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.