Baroreflex Activation Therapy for Heart Failure

Completed · Not applicable

Conditions studied: Heart Failure

In brief

The purpose of this clinical trial (NCT02627196) 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, left ventricular ejection fraction (LVEF) ≤ 35% and NT-proBNP\<1600 pg/ml despite being treated with the appropriate heart failure guideline directed therapy, excluding subjects eligible for or actively receiving Cardiac Resynchronization Therapy (CRT). The total trial duration is anticipated to be approximately 5 years; however, the duration of an individual subject enrollment will depend on when he or she entered the trial.

Key facts

Study ID

NCT02627196

Run by

CVRx, Inc.

People needed

1090

Starts

2016-04-19

Expected to finish

2023-10-01

Last updated by the study team

2026-03-10

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 21 years or above.
• Currently NYHA Class II or III heart failure. For NYHA Class II, must have been NYHA Class III at any point in time within 3 calendar months prior to enrollment or at time of screening (enrollment is defined as the date the subject provided written consent).
• Left ventricular ejection fraction ≤ 35% within 45 days prior to randomization.
• Heart failure accompanied by either:
• Core lab NT-proBNP ≥ 400 AND <1600 pg/ml within 45 days prior to randomization OR
• Core lab NT-proBNP < 400 pg/ml within 45 days prior to randomization AND a heart failure hospitalization in the past 12 months.
• Note: Heart failure hospitalization may include an overnight hospital or hospital-based observation unit stay with a primary diagnosis of heart failure or an emergency room visit with a primary diagnosis of heart failure.
• Note: Screening/Baseline core lab NT-proBNP must be collected in an outpatient setting at a time when the subject is thought to be clinically stable.
• 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:
• No more than a 100% increase or a 50% decrease of the dosage of any one medication other than a diuretic.
• Medication changes within a drug class are allowed as long as the equivalent dosage is within the limits specified above.
• Unrestricted changes in diuretics are allowed as long as the subject remains on a diuretic.
• Six-minute hall walk (6MHW) ≥ 150 m AND ≤ 400 m within 45 days prior to randomization.
• The artery planned for the BAROSTIM implant must meet both of the following criteria:
• 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 AND
• No ulcerative carotid arterial plaques AND
• No carotid atherosclerosis producing a 50% or greater reduction in linear diameter in the internal carotid AND
• No carotid atherosclerosis producing a 50% or greater reduction in linear diameter in 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 (e.g., barrier method with spermicide, oral contraceptive, or abstinence) and agree to continue use of this method for the duration of the trial. Women of childbearing potential must have a negative pregnancy test within 14 days prior to randomization.
• Received a standard cardiac work up and is an appropriate candidate for the study and the surgical procedure as determined by a trial cardiologist and a 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 by the CVRx Clinical department.
• Signed a CVRx-approved informed consent form for participation in this trial.

You may not qualify if…

• If any of the following criteria are met, subjects are not eligible for this trial.
• Received cardiac resynchronization therapy (CRT) within six months of randomization, or is actively receiving CRT.
• Currently have a Class I indication for a cardiac resynchronization therapy (CRT) device according to 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.
• Body mass index > 40.
• Serum estimated glomerular filtration rate (eGFR) < 25 mL/min/1.73 m2 within 45 days prior to randomization.
• Recurring resting heart rate of either < 60 bpm or > 100 bpm via clinic measurements within 45 days prior to randomization. (Note: Heart rate <60 bpm 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. This includes pacemaker or ICD implants or battery replacements.
• 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 (e.g. CABG or PTCA)
• 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 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 (e.g. cardiac amyloidosis).
• Severe COPD or severe restrictive lung disease (e.g. requires chronic steroid use or home oxygen use).

Where it is running

• Chan Heart Rhythm Institute — Mesa, Arizona, United States
• Arizona Arrhythmia Research Center — Phoenix, Arizona, United States
• Phoenix Cardiovascular Research Group — Phoenix, Arizona, United States
• Cardiovascular Consultants, Ltd. — Phoenix, Arizona, United States
• Washington Regional Medical Center — Fayetteville, Arkansas, United States
• Central Cardiology Medical Center — Bakersfield, California, United States
• Chula Vista Cardiac Center — Chula Vista, California, United States
• Sharp Grossmont — Chula Vista, California, United States
• Sharp Chula Vista Medical Center — Chula Vista, California, United States
• John Muir Health Clinical Research Center — Concord, California, United States
• University of California, San Francisco - Fresno — Fresno, California, United States
• Herndon Surgery Center — Fresno, California, United States
• Glendale Adventist Medical Center — Glendale, California, United States
• Memorial Health Services — Laguna Hills, California, United States
• Los Alamitos Cardiovascular — Los Alamitos, California, United States
• Southern California Permanente Medical Group — Los Angeles, California, United States
• University of Southern California — Los Angeles, California, United States
• Advanced Cardiovascular Specialists — Mountain View, California, United States
• Hoag Memorial Hospital — Newport Beach, California, United States
• UC Irvine Health — Orange, California, United States
• Desert Heart Regional Medical Center — Palm Springs, California, United States
• Huntington Hospital — Pasadena, California, United States
• Dignity Health — Sacramento, California, United States
• University of California San Francisco — San Francisco, California, United States
• Heart and Rhythm Solutions, PLLC — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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