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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03542123
Other study ID # 700003-02
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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