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

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

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

Study Overview

• Status: Unknown
• Conditions: Heart Failure Acute
• Intervention / Treatment: Device: NeuroTronik 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Panama
  • Panama City, Panama
    • Recruiting
    • Hospital Punta Pacifica
    • Contact: Temístocles Díaz, MD; Phone Number: +507.204.8354; Email: hemcicompany@gmail.com
    • Contact: Elsa Abruzzo; Phone Number: +1.513.236.0857; Email: elsa.abruzzo@neurotronikinc.com
    • Principal Investigator: Temístocles Díaz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Left Ventricular Ejection fraction < 40%, measured in the last year

2. 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.
3. With or without evidence of low perfusion

Exclusion Criteria:

1. Systolic Blood Pressure < 90 mmHg or > 160 mmHg
2. Catecholamine or inotropic therapy within the previous 48 hours
3. Levosimendan within the previous 72 hours
4. Chronic outpatient catecholamine or inotropic therapy
5. Presence of implanted pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy device
6. Presence of or prior vagal nerve stimulator
7. Coronary artery bypass graft surgery, percutaneous coronary intervention, acute myocardial infarction, or valve replacement within prior 1 month
8. Second or third degree heart block
9. History of atrial or ventricular arrhythmias
10. History of mitral or aortic valve stenosis or regurgitation
11. Hypertrophic obstructive or infiltrative cardiomyopathy
12. Prior vagotomy
13. Prior heart transplant
14. Narrow angle glaucoma
15. Renal failure - either on dialysis or serum creatinine > 2.0 mg/dl
16. Hepatic failure - bilirubin, serum glutamic oxaloacetic transaminase, or serum glutamic pyruvic transaminase > four times upper limit of normal
17. Life expectancy < 12 months per physician judgment
18. Women who are pregnant
19. Allergy to fentanyl, midazolam, propofol, eggs, egg products, soybeans, or soy products
20. Subjects unwilling or unable to provide consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Heart Rate	24 hours
Arterial blood pressure	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Cardiac output	24 hours
Pulmonary capillary wedge pressure	24 hours

Collaborators and Investigators

• Sponsor: NeuroTronik Inc.
• Investigators: Principal Investigator: Temístocles Díaz, MD, Hospital Punta Pacífica, Panama City, Panama

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2017
• Primary Completion (Anticipated): May 19, 2019
• Study Completion (Anticipated): June 19, 2019

Study Registration Dates

• First Submitted: May 25, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Heart Failure; Congestive Heart Failure; Parasympathetic Nervous System; Electrodes; Electrical Stimulation Therapy; Sympathetic Fibers; Post Ganglionic
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 700022-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No