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

August 22, 2018 updated by: NeuroTronik Inc.
A single-arm study to observe NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System hemodynamic and other physiologic effects.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: NeuroTronik CANS Therapy® System
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Left ventricular pressure and volume
Time Frame: One hour
One hour

Secondary Outcome Measures

Outcome Measure
Time Frame
Heart rate
Time Frame: One hour
One hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeuroTronik Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 5, 2018

Primary Completion (ANTICIPATED)

June 1, 2019

Study Completion (ANTICIPATED)

July 1, 2019

Study Registration Dates

First Submitted

May 18, 2018

First Submitted That Met QC Criteria

May 18, 2018

First Posted (ACTUAL)

May 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 22, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 700003-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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