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

Heart Failure Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03169803
• Other study ID #: 700022-01
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2017
• Est. completion date: June 19, 2019

Study information

• Verified date: August 2018
• Source: NeuroTronik Inc.
• Contact: Temístocles Díaz, MD
• Phone: +507.204.8354
• Email: hemcicompany[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A feasibility study to investigate the safety and performance of the NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 19, 2019
• Est. primary completion date: May 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure Acute

Intervention

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.

Locations

Country	Name	City	State
Panama	Hospital Punta Pacífica	Panama City

Sponsors (1)

Lead Sponsor	Collaborator
NeuroTronik Inc.

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial blood pressure		24 hours
Primary	Heart Rate		24 hours
Secondary	Cardiac output		24 hours
Secondary	Pulmonary capillary wedge pressure		24 hours