Heart Failure Clinical Trial
— COAST-HF FXOfficial title:
Cardiac Output Autonomic Stimulation Therapy for Heart Failure - Hemodynamic Effects
NCT number | NCT03542123 |
Other study ID # | 700003-02 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 5, 2018 |
Est. completion date | July 1, 2019 |
A single-arm study to observe NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System hemodynamic and other physiologic effects.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | July 1, 2019 |
Est. primary completion date | June 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Normal sinus rhythm by ECG - Men and women 21-75 years old - Patients with stable symptomatic heart failure, New York Heart Association (NYHA) class II, III, or IV. Exclusion Criteria: - Systolic Blood Pressure < 90 mmHg or > 160 mmHg - Current amiodarone therapy or any other antiarrhythmic therapy - Coronary artery bypass graft surgery or percutaneous coronary intervention within prior 1 month - Enzyme-positive MI within prior 1 month - Patients who have been hospitalized for heart failure and who required the use of HF IV therapy within 30 days before enrollment (measured from release) - History of recent severe ventricular arrhythmias - Pre-existing carotid artery or cerebral disease - Patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis) - Patients with prior vagalotomy - Patients with current or prior vagal nerve stimulators - Subjects with narrow angle glaucoma - Renal failure - on dialysis or serum creatinine > 2.0 mg/dl - Hepatic failure - bilirubin, SGOT, or SGPT > 4X upper limit of normal - Patients with a life expectance < 12 months per physician judgment - Women who are pregnant - Allergy to fentanyl, midazolam, propofol, eggs, egg products, soybeans, or soy products - Subjects unwilling or unable to provide consent for the protocol |
Country | Name | City | State |
---|---|---|---|
Paraguay | Sanatorio Italiano | Asunción |
Lead Sponsor | Collaborator |
---|---|
NeuroTronik Inc. |
Paraguay,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Left ventricular pressure and volume | One hour | ||
Secondary | Heart rate | One hour |
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