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

October 12, 2016 updated by: NeuroTronik Inc.
A single-center feasibility study in patients undergoing cardiac catheterization, to investigate the acute hemodynamic effects of transvenous cardiac autonomic nerve stimulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

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 Locations

  • Paraguay
      • Asuncion, Paraguay
        • Sanatorio Italiano

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:

  • 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

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

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Single arm, transvenous cardiac autonomic nerve stimulation
Device: NeuroTronik CANS Therapy System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiac output
Time Frame: One hour
One hour

Secondary Outcome Measures

Outcome Measure
Time Frame
Arterial blood pressure
Time Frame: One hour
One hour
Left ventricular pressure
Time Frame: One hour
One hour
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.

Investigators

  • Principal Investigator: Adrian Ebner, Medical Doctor, Facultad de Ciencias Medicas UNA Paraguay, Asuncion, Paraguay

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

October 1, 2015

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

August 10, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (ESTIMATE)

August 26, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 700019-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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