Cardiac Output Autonomic Stimulation Therapy for Acute Heart Failure (COAST-AHF)
NCT ID: NCT03169803
Last Updated: 2018-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2017-05-19
2019-06-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Single arm, NeuroTronik CANS Therapy System
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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NeuroTronik Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Temístocles Díaz, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Punta Pacífica, Panama City, Panama
Locations
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Hospital Punta Pacífica
Panama City, , Panama
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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700022-01
Identifier Type: -
Identifier Source: org_study_id
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