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

Primary Purpose

Heart Failure Acute, Heart Failure

Status

Unknown status

Phase

Not Applicable

Locations

Paraguay

Study Type

Interventional

Intervention

NeuroTronik CANS Therapy® System

About this trial

This is an interventional device feasibility trial for Heart Failure Acute focused on measuring Electrical Stimulation Therapy; Electrodes; Parasympathetic Nervous System; Sympathetic Fibers, Post Ganglionic; Congestive Heart Failure; Heart Failure

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Sanatorio ItalianoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NeuroTronik CANS Therapy® System

Arm Description

Outcomes

Primary Outcome Measures

Left ventricular pressure and volume

Secondary Outcome Measures

Heart rate

Full Information

NCT ID

NCT03542123

First Posted

May 18, 2018

Last Updated

August 22, 2018

Sponsor

NeuroTronik Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03542123

Brief Title

Cardiac Output Autonomic Stimulation Therapy for Heart Failure - Hemodynamic Effects

Acronym

COAST-HF FX

Official Title

Cardiac Output Autonomic Stimulation Therapy for Heart Failure - Hemodynamic Effects

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

June 5, 2018 (Actual)

Primary Completion Date

June 1, 2019 (Anticipated)

Study Completion Date

July 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NeuroTronik Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure Acute, Heart Failure

Keywords

Electrical Stimulation Therapy; Electrodes; Parasympathetic Nervous System; Sympathetic Fibers, Post Ganglionic; Congestive Heart Failure; Heart Failure

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NeuroTronik CANS Therapy® System

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

NeuroTronik CANS Therapy® System

Intervention Description

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.

Primary Outcome Measure Information:

Title

Left ventricular pressure and volume

Time Frame

One hour

Secondary Outcome Measure Information:

Title

Heart rate

Time Frame

One hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Adrian Ebner, Medical Doctor

Phone

011 595 21 202767

adrian_ebner@yahoo.com

Facility Information:

Facility Name

Sanatorio Italiano

City

Asunción

Country

Paraguay

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Adrian Ebner, MD

Phone

011 595 21 202767

adrian_ebner@yahoo.com

First Name & Middle Initial & Last Name & Degree

Adrian Ebner, MD

12. IPD Sharing Statement

Learn more about this trial

Cardiac Output Autonomic Stimulation Therapy for Heart Failure - Hemodynamic Effects

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