Cardiac Output Autonomic Stimulation Therapy for Heart Failure - Hemodynamic Effects

Heart Failure Clinical Trial

— COAST-HF FX  

Official title:

Cardiac Output Autonomic Stimulation Therapy for Heart Failure - Hemodynamic Effects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03542123
• Other study ID #: 700003-02
• Status: Recruiting
• Phase: N/A
• Start date: June 5, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: August 2018
• Source: NeuroTronik Inc.
• Contact: Adrian Ebner, Medical Doctor
• Phone: 011 595 21 202767
• Email: adrian_ebner[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure Acute

Intervention

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.

Locations

Country	Name	City	State
Paraguay	Sanatorio Italiano	Asunción

Sponsors (1)

Lead Sponsor	Collaborator
NeuroTronik Inc.

Country where clinical trial is conducted

Paraguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular pressure and volume		One hour
Secondary	Heart rate		One hour