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

Not Applicable

• Conditions: Heart Failure Acute
• Interventions: Device: NeuroTronik CANS Therapy™ System

• Registration Number: NCT03169803
• Lead Sponsor: NeuroTronik Inc.

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 Timeline

• Study Start: 2017-05-19
• Study First Submitted: 2017-05-25
• Study First Submitted QC: 2017-05-25
• Study First Posted: 2017-05-30
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-23
• Primary Completion: 2019-05-19
• Study Completion: 2019-06-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm, NeuroTronik CANS Therapy System	NeuroTronik CANS Therapy™ System	-

Primary Outcome Measures

Name	Time	Method
Arterial blood pressure	24 hours
Heart Rate	24 hours

Secondary Outcome Measures

Name	Time	Method
Cardiac output	24 hours
Pulmonary capillary wedge pressure	24 hours

Trial Locations

Locations (1)

Hospital Punta Pacífica; 🇵🇦 Panama City, Panama