Heart Failure Acute
Conditions
Keywords
Electrical Stimulation Therapy, Electrodes, Parasympathetic Nervous System, Sympathetic Fibers, Post Ganglionic, Congestive Heart Failure, Heart Failure
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.
Interventions
DEVICENeuroTronik 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.
Sponsors
NeuroTronik Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Arterial blood pressure | 24 hours |
| Heart Rate | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac output | 24 hours |
| Pulmonary capillary wedge pressure | 24 hours |
Countries
Panama
Contacts
Primary ContactTemístocles Díaz, MD
Backup ContactElsa I Abruzzo
Outcome results
None listed