Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure

Summary

The purpose of BENEFIT-HF is to demonstrate the safety and effectiveness of Baroreflex Activation Therapy (BAT) with the Barostim System in participants with heart failure, defined as NYHA Functional Class II or III, LVEF < 50% and NT-proBNP < 5,000 pg/mL despite being treated with Guideline-Directed Medical Therapies (medications and devices). It includes demonstration that treatment with the Barostim System, relative to usual care medical management, reduces the rate of all-cause mortality and Heart Failure Morbidity (Cardiac Transplant, Durable LVAD, or Worsening Heart Failure Events).

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Heart Failure
• Heart Failure NYHA Class II
• Heart Failure NYHA Class III

Eligibility basics and study details

Study type

Interventional

Phase

Not applicable

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

CVRx, Inc.

Last updated on ClinicalTrials.gov

September 23, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites