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Benefit-HF

A landmark study expected to be one of the largest therapeutic cardiac device trials ever performed in heart failure

~150
Centers in the U.S. and Germany
2,500
Randomized patients
24
Month Follow-up (enrollment expected 2026 to 2030)
Endpoints
Primary composite endpoint of all-cause mortality, LVAD, transplant, and hospitalization events
Key patient inclusion criteria
  • NYHA Class II or III
  • LVEF <50%
  • NT-proBNP 400-5,000 pg/mL
  • Symptomatic despite receiving optimized guideline-directed medical therapy (GDMT) (medications and devices)
*For full inclusion criteria visit clinicaltrials.gov NCT07232030.
Trial schematic
BENEFIT-HF is a prospective, randomized, controlled, multicenter clinical trial. Eligible participants will be randomized in a 2:1 ratio to receive Baroreflex Activation Therapy (BAT) with an implanted Barostim System in addition to usual care medical management (Device Arm) or to receive usual care medical management alone with no device implant (Control Arm).

Visit clinicaltrials.gov NCT07232030 for additional study information.

For more information about BENEFIT-HF contact:

CVRx Medical Affairs & Clinical Research
[email protected]

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.