NCT07232030

Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure

Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure (BENEFIT-HF)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,500 (estimated)
• Sponsor: CVRx, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

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

Interventions

Type	Name	Description
DEVICE	Barostim System	Baroreflex Activation Therapy (BAT) using the Barostim System
OTHER	Usual care medical management	Usual care medical management alone - no device implant

Timeline

• Start date: 2026-04-01
• Primary completion: 2033-01-01
• Completion: 2033-01-01
• First posted: 2025-11-18
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study