Clinical trial NCT02880683: Cardiac Output Autonomic Stimulation Therapy for Heart Failure (COAST-HF) - Human NeuroCatheter Study
Official title: Cardiac Output Autonomic Stimulation Therapy for Heart Failure (COAST-HF) - Human NeuroCatheter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Output, Low
Keywords: Electrical Stimulation Therapy
Parasympathetic Nervous System
Sympathetic Fibers
Post Ganglionic
Congestive Heart Failure
Heart Failure
Lead sponsor: NeuroTronik Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-26
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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

Primary outcomes:
measure: Cardiac output
timeFrame: One hour
Secondary outcomes:
measure: Arterial blood pressure
timeFrame: One hour
measure: Left ventricular pressure
timeFrame: One hour
measure: Heart rate
timeFrame: One hour
Other outcomes:
Locations:
city: Asuncion
country: Paraguay
facility: Sanatorio Italiano
Study officials:
affiliation: Facultad de Ciencias Medicas UNA Paraguay, Asuncion, Paraguay
name: Adrian Ebner, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
References: