BENEFIT-HF

What is Barostim Therapy?

Barostim is an FDA-approved implantable device that has been shown to safely reduce the symptoms of heart failure (HF) and improve quality of life.1 The device works by sending gentle electrical signals to natural pressure sensors in the neck that help rebalance the body’s nervous system and reduce strain on the heart. Most patients who receive Barostim already have an existing pacemaker, ICD, or CRT device. 

1. Zile MR, et al. Eur J Heart Fail. 2024; 26:1051-1061

BENEFIT-Study

The BENEFIT-HF Study

BENEFIT-HF is a study to learn about how Barostim can help a greater number of people with HF

The study will determine if Barostim:

  • Reduces serious events like hospital stays, transplants, or death
  • Improves symptoms and is safe for the expanded group of patients

Participants will be randomly placed (by chance, like flipping a coin) into
one of two study groups:

  • Barostim with HF medications
  • HF medications only

Random assignment helps researchers compare results fairly. Neither you nor your doctor can choose your group.

Who may be Eligible?

  •  Diagnosed with HF and are taking standard medications
  •  Have reduced heart pumping function (ejection fraction)
  •  Meet specific HF lab criteria

Why participate in the Study:

  • Gain Access to an innovative HF therapy
  • Receive expert HF care while continuing to see your current care team.
  • Contribute to research that may benefit future HF patients 

What does Participation involve? 

1. Screening visit (day 1)
Your study doctor will review your medical history and perform tests to determine if the study
may be right for you.

2. Potential implant (~day 45)
If you qualify, you will be randomly placed in one of two study groups; Barostim with HF
medications or HF medications alone

3. Follow-up visits (over 2 years)
Regular visits with your care team at 6,12, and 24 months to monitor your health and
progress.

The Barostim System is FDA-approved and indicated for patients who are NYHA Class III or Class II (who had a recent history of Class III) despite treatment with guideline-directed medical therapies (medications and devices), have a left ventricular ejection fraction of ≤ 35%, and a NT-proBNP <1600 pg/mL. Barostim delivers Baroreflex Activation Therapy for improvement of patients’ heart failure functional status,  six-minute hall walk, and quality of life. BENEFIT-HF is a clinical trial evaluating Barostim in an expanded heart failure population. While this trial includes patients within the currently approved indication, it also includes an expanded population for whom the safety and effectiveness of the device have not yet been established. Barostim is not FDA-approved for use in this expanded patient population. CAUTION: Investigational use of device. Federal law restricts this device to sale by or on the order of a physician. See Instructions for Use (900133-001) for complete instructions for use and a description of indications, contraindications, warnings, precautions and adverse events.CVRx, Barostim, BAT, Barostim NEO2, and Outsmart the heart are all trademarks of CVRx, Inc. © 2026 CVRx, Inc. All rights reserved. All other trademarks are property of their respective owners. This document is intended for informational purposes only. CVRx Clinical and Medical Affairs are leading all trial execution and site selection. This document does not represent an invitation to participate in the trial.