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Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure

NCT07232030 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2500

Last updated 2026-04-29

No results posted yet for this study

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

DEVICE

Barostim System

Baroreflex Activation Therapy (BAT) using the Barostim System

OTHER

Usual care medical management

Usual care medical management alone - no device implant

Sponsors & Collaborators

  • CVRx, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2033-01-31
Completion
2033-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07232030 on ClinicalTrials.gov