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

Not Applicable

Completed

• Conditions: Cardiac Output, Low
• Interventions: Device: NeuroTronik CANS Therapy System

• Registration Number: NCT02880683
• Lead Sponsor: NeuroTronik Inc.

Brief Summary

A single-center feasibility study in patients undergoing cardiac catheterization, to investigate the acute hemodynamic effects of transvenous cardiac autonomic nerve stimulation.

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-22
• Study First Posted: 2016-08-26
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm, transvenous cardiac autonomic nerve stimulation	NeuroTronik CANS Therapy System	-

Primary Outcome Measures

Name	Time	Method
Cardiac output	One hour

Secondary Outcome Measures

Name	Time	Method
Arterial blood pressure	One hour
Left ventricular pressure	One hour
Heart rate	One hour

Trial Locations

Locations (1)

Sanatorio Italiano; 🇵🇾 Asuncion, Paraguay