Barostim Neo® - Baroreflex Activation Therapy® for Heart Failure
a study on Heart Failure
The purpose of this trial is to develop valid scientific evidence for safety and effectiveness of Baroreflex Activation Therapy® with the BAROSTIM NEO® System in subjects with heart failure, defined as New York Heart Association (NYHA) functional class III and left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate heart failure guideline directed therapy, excluding subjects eligible for or actively receiving Cardiac Resynchronization Therapy (CRT).
Heart Failure BAROSTIM NEO® Baroreceptor Baroreflex Baroreflex Activation Therapy™ New York Heart Associate Class III Heart Failure BAROSTIM NEO® System
You can join if…
Open to people ages 21 years and up
- Currently NYHA Class II or III heart failure.
- Left ventricular ejection fraction ≤ 35% within 45 days prior to randomization.
- Heart failure accompanied by a BNP ≥ 100 or NT-proBNP ≥ 400 within 45 days prior to randomization, or a heart failure hospitalization in the past 12 months
- On optimal, stable, Guideline Directed Medical Therapy (GDMT) per country specific guidelines for the treatment of heart-failure throughout screening/baseline evaluation and for at least 4 weeks prior to obtaining any post-consent screening parameters.
- Six-minute hall walk (6MHW) ≥ 150m AND ≤ 400m within 45 days prior to randomization.
- The artery planned for the BAROSTIM implant must have:
- At least one carotid bifurcation as identification by a bilateral carotid duplex ultrasound within 6 months prior to randomization that is:
- Below the level of the mandible
- Has no ulcerative carotid arterial plaques
- Has no carotid atherosclerosis producing at 50% or greater reduction in linear diameter of the internal carotid
- Has no carotid atherosclerosis producing at 50% or greater reduction in linear diameter of the distal common carotid
- No prior surgery, radiation, or endovascular stent placement in the carotid artery or the carotid sinus region.
- If female and of childbearing potential, must use a medically accepted method of birth control and have a negative pregnancy test within 14 days of randomization.
- Received a standard cardiac work up and is an appropriate candidate for the study and the surgical procedure as determine by a trial cardiologist and trial surgeon.
- Subjects implanted with a cardiac rhythm management device that does not utilize an intracardiac lead, or implanted with a neurostimulation device, must be approved prior to enrollment.
- . Signed a CVRx-approved informed consent form for participation in this trial.
You CAN'T join if...
- Received cardiac resynchronization therapy (CRT) within 6 months of randomization, or is actively receiving CRT.
- Currently have a Class I indication for a cardiac resynchronization therapy (CRT) device according to the American Heart Association/American College of Cardiology/European Society of Cardiology (AHA/ACC/ESC) guidelines for the treatment of congestive heart failure.
- Known or suspected baroreflex failure or autonomic neuropathy.
- AHA/ACC Stage D heart failure within 45 days prior to randomization.
- BMI > 40.
Serum estimated glomerular filtration rate (eGFR) < 25 mL/min/173m2 within 45 days prior to randomization.
- Recurring resting heart rate of either < 60 beats per minute(bpm) or > 100 bpm via clinic measurements within 45 days prior to randomization. (Heart rate of < 60bpm is not applicable to subjects with an implanted device capable of pacing).
- Recurring symptomatic hypotension within 45 days prior to randomization.
- Significant uncontrolled symptomatic bradyarrhythmias or unstable ventricular arrhythmias.
- . Subjects with any surgery that has occurred, or is planned to occur, within 45 days of the BAROSTIM NEO® implant procedure.
- . Episode of NYHA class IV heart failure with acute pulmonary edema within 45 days prior to randomization.
- . Any of the following within 3 months of randomization:
- Myocardial infarction
- Unstable angina
- Percutaneous coronary intervention
- Cerebral vascular accident or transient ischemic attack
- Sudden cardiac death
- . Solid organ or hematologic transplant, or currently being actively evaluated for an organ transplant.
- . Has received or is receiving left ventricular assist device (LVAD) therapy.
- . Has received or is receiving chronic dialysis.
- . Heart failure secondary to a reversible cause, such as cardiac structural valvular disease, acute myocarditis and pericardial constriction.
- . Primary pulmonary hypertension.
- . Infiltrative cardiomyopathy.
- . Severe chronic obstructive pulmonary disease (COPD) or severe restrictive lung disease.
- . Active malignancy.
- . Current or planned treatment with intravenous positive inotrope therapy
- . Life expectancy less than one year.
- . Clinically significant psychological condition that, in the physician's opinion, would prohibit the subject's ability to meet the protocol requirements.
- . Unable or unwilling to fulfill the protocol medication compliance, testing, and follow-up requirements.
- . Enrolled and active in another clinical trial (unless previously approved by the CVRx Clinical Department).
- . Subjects with known allergies to silicone and titanium
- University of California, San Francisco - Fresno
Fresno California 93701 United States
- University of California San Francisco
San Francisco California 94143 United States
- Herndon Surgery Center
Fresno California 93720 United States