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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
Active, not recruiting |
NCT05896904 -
Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction
|
N/A | |
Completed |
NCT05077293 -
Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
|
||
Recruiting |
NCT05631275 -
The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
|
||
Enrolling by invitation |
NCT05564572 -
Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
|
N/A | |
Enrolling by invitation |
NCT05009706 -
Self-care in Older Frail Persons With Heart Failure Intervention
|
N/A | |
Recruiting |
NCT04177199 -
What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
|
||
Terminated |
NCT03615469 -
Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)
|
N/A | |
Recruiting |
NCT06340048 -
Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure
|
Phase 1/Phase 2 | |
Recruiting |
NCT05679713 -
Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
|
||
Completed |
NCT04254328 -
The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure
|
N/A | |
Completed |
NCT03549169 -
Decision Making for the Management the Symptoms in Adults of Heart Failure
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05538611 -
Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
|
||
Recruiting |
NCT04262830 -
Cancer Therapy Effects on the Heart
|
||
Completed |
NCT06026683 -
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
|
N/A | |
Withdrawn |
NCT03091998 -
Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support
|
Phase 1 | |
Recruiting |
NCT05564689 -
Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
|