Cardiac Output Autonomic Stimulation Therapy for Heart Failure - Hemodynamic Effects

Not Applicable

• Conditions: Heart Failure; Heart Failure Acute
• Interventions: Device: NeuroTronik CANS Therapy® System

• Registration Number: NCT03542123
• Lead Sponsor: NeuroTronik Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2018-05-18
• Study First Posted: 2018-05-31
• Study Start: 2018-06-05
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-23
• Primary Completion: 2019-06-01
• Study Completion: 2019-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NeuroTronik CANS Therapy® System	NeuroTronik CANS Therapy® System	-

Primary Outcome Measures

Name	Time	Method
Left ventricular pressure and volume	One hour

Secondary Outcome Measures

Name	Time	Method
Heart rate	One hour

Trial Locations

Locations (1)

Sanatorio Italiano; 🇵🇾 Asunción, Paraguay