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Trial record 8 of 284 for:    Panama

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE May 25, 2017
First Posted Date  ICMJE May 30, 2017
Last Update Posted Date August 23, 2018
Actual Study Start Date  ICMJE May 19, 2017
Estimated Primary Completion Date May 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2017)
  • Arterial blood pressure [ Time Frame: 24 hours ]
  • Heart Rate [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03169803 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2017)
  • Cardiac output [ Time Frame: 24 hours ]
  • Pulmonary capillary wedge pressure [ Time Frame: 24 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cardiac Output Autonomic Stimulation Therapy for Acute Heart Failure (COAST-AHF)
Official Title  ICMJE Cardiac Output Autonomic Stimulation Therapy for Acute Heart Failure (COAST-AHF) - System Design Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Heart Failure Acute
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Single arm, NeuroTronik CANS Therapy System
Intervention: Device: NeuroTronik CANS Therapy™ System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 25, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 19, 2019
Estimated Primary Completion Date May 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Temístocles Díaz, MD +507.204.8354 hemcicompany@gmail.com
Contact: Elsa I Abruzzo +1.513.236.0857 elsa.abruzzo@neurotronikinc.com
Listed Location Countries  ICMJE Panama
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03169803
Other Study ID Numbers  ICMJE 700022-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party NeuroTronik Inc.
Study Sponsor  ICMJE NeuroTronik Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Temístocles Díaz, MD Hospital Punta Pacífica, Panama City, Panama
PRS Account NeuroTronik Inc.
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP