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

NCT ID: NCT02880683

Last Updated: 2016-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-09-30

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.

Conditions

Cardiac Output, Low

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Single arm, transvenous cardiac autonomic nerve stimulation

Group Type: EXPERIMENTAL

NeuroTronik CANS Therapy System

Intervention Type: DEVICE

Interventions

NeuroTronik CANS Therapy System

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NeuroTronik Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrian Ebner, Medical Doctor

Role: PRINCIPAL_INVESTIGATOR

Facultad de Ciencias Medicas UNA Paraguay, Asuncion, Paraguay

Locations

Sanatorio Italiano

Asunción, , Paraguay

Countries

Paraguay

Other Identifiers

700019-01

Identifier Type: -

Identifier Source: org_study_id