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

Cardiac Output, Low Clinical Trial

— COAST-HF HNrCS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02880683
• Other study ID #: 700019-01
• Status: Completed
• Phase: N/A
• First received: August 10, 2016
• Last updated: October 12, 2016
• Start date: October 2015
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: NeuroTronik Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Paraguay: Ministerio de Salud Pública y Bienestar Social
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cardiac Output, Low
• Heart Failure

Intervention

Device:
• NeuroTronik CANS Therapy System

Locations

Country	Name	City	State
Paraguay	Sanatorio Italiano	Asuncion

Sponsors (1)

Lead Sponsor	Collaborator
NeuroTronik Inc.

Country where clinical trial is conducted

Paraguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output		One hour	No
Secondary	Arterial blood pressure		One hour	No
Secondary	Left ventricular pressure		One hour	No
Secondary	Heart rate		One hour	No