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

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ClinicalTrials.gov Identifier: NCT03169803
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
NeuroTronik Inc.

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Estimated Primary Completion Date : May 19, 2019
Estimated Study Completion Date : June 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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.




Primary Outcome Measures :
  1. Arterial blood pressure [ Time Frame: 24 hours ]
  2. Heart Rate [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Cardiac output [ Time Frame: 24 hours ]
  2. Pulmonary capillary wedge pressure [ Time Frame: 24 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03169803


Contacts
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Contact: Temístocles Díaz, MD +507.204.8354 hemcicompany@gmail.com
Contact: Elsa I Abruzzo +1.513.236.0857 elsa.abruzzo@neurotronikinc.com

Locations
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Panama
Hospital Punta Pacífica Recruiting
Panama City, Panama
Contact: Temístocles Díaz, MD    +507.204.8354    hemcicompany@gmail.com   
Contact: Elsa Abruzzo    +1.513.236.0857    elsa.abruzzo@neurotronikinc.com   
Principal Investigator: Temístocles Díaz, MD         
Sponsors and Collaborators
NeuroTronik Inc.
Investigators
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Principal Investigator: Temístocles Díaz, MD Hospital Punta Pacífica, Panama City, Panama

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Responsible Party: NeuroTronik Inc.
ClinicalTrials.gov Identifier: NCT03169803     History of Changes
Other Study ID Numbers: 700022-01
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NeuroTronik Inc.:
Electrical Stimulation Therapy
Electrodes
Parasympathetic Nervous System
Sympathetic Fibers
Post Ganglionic
Congestive Heart Failure
Heart Failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases