Cardiac Output Autonomic Stimulation Therapy for Acute Heart Failure (COAST-AHF)

Sponsor

NeuroTronik Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03169803

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A feasibility study to investigate the safety and performance of the NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Acute	Device: NeuroTronik CANS Therapy™ System	N/A

Detailed Description

A single-arm, safety study intended to assess safety and system performance, and the feasibility to improve hemodynamics in patients with acute heart failure syndrome using transvenous, cardiac autonomic nerve stimulation (CANS) therapy. In addition, the effects of NeuroTronik CANS Therapy™ on the congestion of patients will be studied. The study proposes that the NeuroTronik CANS Therapy™ System be deployed during the acute heart failure syndrome hospital admission, along with existing standard treatment.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

Cardiac Output Autonomic Stimulation Therapy for Acute Heart Failure (COAST-AHF) - System Design Study

Actual Study Start Date :

May 19, 2017

Anticipated Primary Completion Date :

May 19, 2019

Anticipated Study Completion Date :

Jun 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single arm, NeuroTronik CANS Therapy System	Device: NeuroTronik CANS Therapy™ System The NeuroTronik CANS Therapy™ System is a percutaneous, catheter-based, bedside electrical stimulation system. The System consists of the single-use, disposable NeuroCatheter™ and NeuroCatheter™ Placement Kit, along with the reusable, bedside NeuroModulator™ Development System, and the NeuroTronik CANS Therapy™ Cable.

Arm

Intervention/Treatment

Experimental: Single arm, NeuroTronik CANS Therapy System

Device: NeuroTronik CANS Therapy™ System

The NeuroTronik CANS Therapy™ System is a percutaneous, catheter-based, bedside electrical stimulation system. The System consists of the single-use, disposable NeuroCatheter™ and NeuroCatheter™ Placement Kit, along with the reusable, bedside NeuroModulator™ Development System, and the NeuroTronik CANS Therapy™ Cable.

Outcome Measures

Primary Outcome Measures

Arterial blood pressure [24 hours]
Heart Rate [24 hours]

Secondary Outcome Measures

Cardiac output [24 hours]
Pulmonary capillary wedge pressure [24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Left Ventricular Ejection fraction < 40%, measured in the last year
At least two of the following:

Pulmonary Capillary Wedge Pressure > 18 mmHg
Pulmonary congestion on Chest X-ray
Jugular vein distension
Pulmonary rales
Edema
Dyspnea at rest
Two (2) emergency room visits or hospital admissions in the past three (3) months, or three (3) emergency room visits or admissions in the past six (6) months requiring intravenous diuretics, ultrafiltration or in-hospital inotropic therapy.

With or without evidence of low perfusion

Exclusion Criteria:

Systolic Blood Pressure < 90 mmHg or > 160 mmHg
Catecholamine or inotropic therapy within the previous 48 hours
Levosimendan within the previous 72 hours
Chronic outpatient catecholamine or inotropic therapy
Presence of implanted pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy device
Presence of or prior vagal nerve stimulator
Coronary artery bypass graft surgery, percutaneous coronary intervention, acute myocardial infarction, or valve replacement within prior 1 month
Second or third degree heart block
History of atrial or ventricular arrhythmias
History of mitral or aortic valve stenosis or regurgitation
Hypertrophic obstructive or infiltrative cardiomyopathy
Prior vagotomy
Prior heart transplant
Narrow angle glaucoma
Renal failure - either on dialysis or serum creatinine > 2.0 mg/dl
Hepatic failure - bilirubin, serum glutamic oxaloacetic transaminase, or serum glutamic pyruvic transaminase > four times upper limit of normal
Life expectancy < 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