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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03169803
• Date of registration: 25/05/2017
• Prospective Registration: No
• Primary sponsor: NeuroTronik Inc.
• Public title: Cardiac Output Autonomic Stimulation Therapy for Acute Heart Failure (COAST-AHF)
• Scientific title: Cardiac Output Autonomic Stimulation Therapy for Acute Heart Failure (COAST-AHF) - System Design Study
• Date of first enrolment: May 19, 2017
• Target sample size: 40
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03169803
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Device Feasibility. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Panama

Contacts

• Name: Temístocles Díaz, MD
• Affiliation: Hospital Punta Pacífica, Panama City, Panama

• Name: Temístocles Díaz, MD

• Name: Temístocles Díaz, MD

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Heart Failure Acute

Intervention(s)

Device: NeuroTronik CANS Therapy™ System

Primary Outcome(s)

Arterial blood pressure [Time Frame: 24 hours]

Heart Rate [Time Frame: 24 hours]

Secondary Outcome(s)

Pulmonary capillary wedge pressure [Time Frame: 24 hours]

Cardiac output [Time Frame: 24 hours]

Secondary ID(s)

700022-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors