Back to results

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

Primary Purpose

Heart Failure Acute

Status

Unknown status

Phase

Not Applicable

Locations

Panama

Study Type

Interventional

Intervention

NeuroTronik CANS Therapy™ System

About this trial

This is an interventional device feasibility trial for Heart Failure Acute focused on measuring Electrical Stimulation Therapy, Electrodes, Parasympathetic Nervous System, Sympathetic Fibers, Post Ganglionic, Congestive Heart Failure, Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hospital Punta PacíficaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm, NeuroTronik CANS Therapy System

Arm Description

Outcomes

Primary Outcome Measures

Arterial blood pressure

Heart Rate

Secondary Outcome Measures

Cardiac output

Pulmonary capillary wedge pressure

Full Information

NCT ID

NCT03169803

First Posted

May 25, 2017

Last Updated

August 22, 2018

Sponsor

NeuroTronik Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03169803

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 19, 2017 (Actual)

Primary Completion Date

May 19, 2019 (Anticipated)

Study Completion Date

June 19, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NeuroTronik Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure Acute

Keywords

Electrical Stimulation Therapy, Electrodes, Parasympathetic Nervous System, Sympathetic Fibers, Post Ganglionic, Congestive Heart Failure, Heart Failure

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single arm, NeuroTronik CANS Therapy System

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

NeuroTronik CANS Therapy™ System

Intervention Description

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.

Primary Outcome Measure Information:

Title

Arterial blood pressure

Time Frame

24 hours

Title

Heart Rate

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Cardiac output

Time Frame

24 hours

Title

Pulmonary capillary wedge pressure

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Temístocles Díaz, MD

Phone

+507.204.8354

hemcicompany@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Elsa I Abruzzo

Phone

+1.513.236.0857

elsa.abruzzo@neurotronikinc.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Temístocles Díaz, MD

Organizational Affiliation

Hospital Punta Pacífica, Panama City, Panama

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Punta Pacífica

City

Panama City

Country

Panama

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Temístocles Díaz, MD

Phone

+507.204.8354

hemcicompany@gmail.com

First Name & Middle Initial & Last Name & Degree

Elsa Abruzzo

Phone

+1.513.236.0857

elsa.abruzzo@neurotronikinc.com

First Name & Middle Initial & Last Name & Degree

Temístocles Díaz, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs