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Barostim System for Heart Failure

This study, called BENEFIT-HF, is testing a device called the Barostim System for people with heart failure. The Barostim System uses Baroreflex Activation Therapy (BAT) to help your heart. Researchers want to see if this device is safe and effective compared to usual medical care for people with heart failure (NYHA Class II or III) and a left ventricular ejection fraction (LVEF) less than 50%. You might be able to join if your NT-proBNP (a blood test for heart failure) is within a certain range. The study aims to see if the Barostim System can reduce deaths and heart failure-related problems like needing a heart transplant. The current status of this study is unclear.

Study design
This study plans to enroll 2500 participants. It compares the Barostim System to usual medical care.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for effectiveness through 24 months after treatment, and for safety within 180 days of device implant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07232030

Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure

Recruiting
NAAges 18+InterventionalTreatment
CVRx, Inc.
~2,500 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Barostim SystemUsual care medical management

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Effectiveness Endpoint
Measured over Through 24-months follow-up
+1 more outcome measured

Conditions

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

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Where it's being run

9 sites across 6 states
Florida4
Alabama1
Ohio1
South Dakota1
Tennessee1
Texas1

Who to contact

Christina Dierkhising
[email protected]
+1 763-416-2870
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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. 6. Six-minute hall walk (6MHW) ≥ 100 m AND ≤ 450 m within 15 days after consent. 7. If female and of childbearing potential, must have a negative pregnancy test within 15 days after consent. 8. Be an appropriate candidate for the trial and the surgical procedure as determined by the investigator or designee and the surgeon. 9. Have signed an informed consent form for participation in this trial.

Exclusion

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. 4. Serum estimated glomerular filtration rate (eGFR) \< 20 mL/min/1.73 m2 or has end-stage renal disease. 5. Recurring symptomatic hypotension. 6. Life expectancy less than one year. 7. 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.
Heart failure secondary to a reversible cause, such as cardiac structural valvular disease, acute myocarditis and pericardial constriction.
Active malignancy with the exception of non-melanoma skin cancers.
Infiltrative cardiomyopathy (e.g. cardiac amyloidosis).
Any other serious medical condition that may adversely affect the safety of the participant or validity of the trial, in the opinion of the investigator. 8. Any of the following within 3 months prior to consent:
Myocardial infarction
Unstable angina
Percutaneous coronary intervention (e.g. PTCA)
Cerebral vascular accident or transient ischemic attack
Cardiac arrest
Surgical cardiac intervention (e.g., CABG, cardiac ablation, valve replacement, CRT/ICD implantation, IPG battery replacements) 9. Surgery planned to occur within 45 days of the Barostim implant procedure. This includes pacemaker or ICD implants or battery replacements. 10. Enrolled and active in another clinical trial (e.g. device, pharmaceutical, or biological) unless approved by the CVRx Clinical Research department. 11. Unable or unwilling to fulfill the Protocol medication compliance and follow-up requirements, for reasons including but not limited to an unresolved history of alcohol or substance abuse or psychiatric disorder. Participant is a member of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, persons in nursing homes, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also include university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

What this trial measures

  • Primary Effectiveness EndpointThrough 24-months follow-up

    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.

  • Primary Safety EndpointWithin 180 days of the device implant

    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.