RecruitingNot ApplicableNCT07232030

Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure

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


Sponsor

CVRx, Inc.

Enrollment

2,500 participants

Start Date

Apr 24, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Barostim System and Usual care medical management for people with heart failure, heart failure nyha class ii, and other related conditions. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBarostim System

Baroreflex Activation Therapy (BAT) using the Barostim System

OTHERUsual care medical management

Usual care medical management alone - no device implant


Locations(11)

Cardiology Associates of Mobile

Mobile, Alabama, United States

BayCare Health System

Clearwater, Florida, United States

First Coast Cardiovascular Institute

Jacksonville, Florida, United States

Tallahassee Research Institute

Tallahassee, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

BayCare Health Systems

Tampa, Florida, United States

The Christ Hospital

Cincinnati, Ohio, United States

North Central Heart

Sioux Falls, South Dakota, United States

Erlanger Health

Chattanooga, Tennessee, United States

CHRISTUS Trinity Mother Frances

Tyler, Texas, United States

Marshfield Clinic Research Institute

Marshfield, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07232030


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