Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure

NCT07232030 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 360069-001
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint

  Composite of all-cause mortality and Heart Failure Morbidity, defined as Cardiac Transplant, Durable LVAD, or Worsening Heart Failure Events, assessed through 24 months of follow-up.

  Through 24-months follow-up

• Primary Safety Endpoint

  The event-free rate of all system- and procedure-related Major Adverse Neurological and Cardiovascular Events (MANCE) occurring within 180 days of the device implant, assessed among participants who were randomized to the Device Arm and in whom an implant has been achieved or attempted.

  Within 180 days of the device implant

Secondary Outcomes (5)

• Quality of Life (QoL) Score Change

  12-months follow-up

• 6MHW distance change

  12-months follow-up

• Days lost to death or hospitalization

  24-months follow-up

• NT-proBNP level change

  12-months follow up

• All-cause mortality

  24-months follow-up

Study Arms (2)

Device Arm

EXPERIMENTAL

Participants will receive Baroreflex Activation Therapy (BAT) with an implanted Barostim System in addition to usual care medical management.

Device: Barostim System

Control Arm

ACTIVE COMPARATOR

Participants will receive usual care medical management alone with no Barostim System device implant.

Other: Usual care medical management

Interventions

Barostim System DEVICE

Baroreflex Activation Therapy (BAT) using the Barostim System

Device Arm

Usual care medical management OTHER

Usual care medical management alone - no device implant

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or above
• NYHA Functional Class II or III heart failure symptoms at the time of screening
• Left ventricular ejection fraction \< 50% within 6 months of consent
• Heart failure accompanied by either:
• Screening local lab NT-proBNP ≥ 400 AND \< 5,000 pg/mL or a BNP ≥100 AND \< 1,250 pg/mL, adjusted for BMI in a stable outpatient setting OR
• A documented Worsening Heart Failure Event in the 6 months prior to or concurrent with consent, AND an NT-proBNP \< 5,000 pg/mL or BNP \< 1,250 pg/mL, adjusted for BMI in a stable outpatient setting.
• Note: If participant is taking sacubitril/valsartan (i.e. Entresto®), NT-proBNP must be used for screening eligibility. NT-proBNP and BNP to be adjusted for BMI using a 4% reduction per BMI unit over 25 kg/m2.
• On optimal, maximally tolerated Guideline Directed Medical Therapy (GDMT) (medications and devices) per current country specific guidelines (e.g. US follows AHA/ACC guidelines, Germany follows DGK/ESC guidelines) for the treatment of heart failure, when appropriate, throughout screening/baseline evaluation and for at least 4 weeks prior to consent:
• No more than a 100% increase or a 50% decrease of the dosage of any one medication other than an oral diuretic.
• Medication changes within a drug class are allowed as long as the equivalent dosage is within the limits specified above.
• Unrestricted changes in oral diuretics are allowed.
• For participants with LVEF between 40-50%, SGLT2 inhibitors and mineralocorticoid receptor antagonists (MRAs) are encouraged and should be initiated before consent when possible.
• Six-minute hall walk (6MHW) ≥ 100 m AND ≤ 450 m within 15 days after consent.
• If female and of childbearing potential, must have a negative pregnancy test within 15 days after consent.
• Be an appropriate candidate for the trial and the surgical procedure as determined by the investigator or designee and the surgeon.

You may not qualify if:

• Any contraindications to Barostim as noted in Instructions for Use.
• An existing device which contraindicates Barostim specifically or unipolar therapy in general.
• Advanced heart failure defined by any of the following:
• AHA/ACC Stage D heart failure.
• Two or more NT-proBNP results \>5,000 pg/mL or BNP \>1,250 pg/mL in a stable outpatient setting within 3 months prior to consent. If participant is taking sacubitril/valsartan (i.e. Entresto®), NT-proBNP must be used for screening eligibility.
• Current or prior continuous or intermittent intravenous positive inotrope therapy.
• Has received, is receiving, or scheduled to receive LVAD therapy.
• Solid organ or hematologic transplant or currently being evaluated for cardiac transplant.
• Serum estimated glomerular filtration rate (eGFR) \< 20 mL/min/1.73 m2 or has end-stage renal disease.
• Recurring symptomatic hypotension.
• Life expectancy less than one year.
• An inappropriate trial candidate as evidenced by at least one of the following:
• Has received or is receiving chronic dialysis.
• Is within WHO groups 1, 3, 4, or 5 pulmonary hypertension.
• Severe COPD or severe restrictive lung disease requiring chronic oral steroid use or any oxygen use.

Sponsors & Collaborators

• CVRx, Inc.: lead

Study Sites (2)

BayCare Health Systems

Tampa, Florida, 33614, United States

Location

North Central Heart

Sioux Falls, South Dakota, 57108, United States

Location

Related Links

• Sponsor website

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, controlled, multicenter clinical trial. Eligible participants will be randomized in a 2:1 ratio to receive Baroreflex Activation Therapy (BAT) with an implanted Barostim System in addition to usual care medical management (Device Arm) or to receive usual care medical management alone with no device implant (Control Arm).

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2033
• Study Completion (Estimated): January 1, 2033
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)