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

Sponsor
NeuroTronik Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03542123
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
12.8
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: NeuroTronik CANS Therapy® System
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Cardiac Output Autonomic Stimulation Therapy for Heart Failure - Hemodynamic Effects
Actual Study Start Date :
Jun 5, 2018
Anticipated Primary Completion Date :
Jun 1, 2019
Anticipated Study Completion Date :
Jul 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Left ventricular pressure and volume [One hour]

Secondary Outcome Measures

  1. Heart rate [One hour]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sanatorio Italiano Asunción Paraguay

Sponsors and Collaborators

  • NeuroTronik Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NeuroTronik Inc.
ClinicalTrials.gov Identifier:
NCT03542123
Other Study ID Numbers:
  • 700003-02
First Posted:
May 31, 2018
Last Update Posted:
Aug 23, 2018
Last Verified:
Aug 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by NeuroTronik Inc.
Electrical Stimulation Therapy; Electrodes; Parasympathetic Nervous System; Sympathetic Fibers, Post Ganglionic; Congestive Heart Failure; Heart Failure
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Aug 23, 2018