Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure

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).

NCT Number	NCT07232030
Lead Sponsor	CVRx, Inc.
Conditions	Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III
Enrollment	2,500 participants
Start Date	2026-04-24
Primary Completion	2033-01 (estimated)
Study Completion	2033-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-11