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Barostimulation for Heart Failure with Reduced Ejection Fraction (HFrEF)

This study is looking at how a device called Barostim™ (made by CVRx Inc.) helps adults with heart failure with reduced ejection fraction (HFrEF). HFrEF means your heart can't pump enough blood to your body. The Barostim™ device is already approved by the FDA and works by stimulating nerves to improve heart function. You might be able to join if you have HFrEF with an ejection fraction of 35% or less, and still have symptoms despite taking all your heart medications. The study wants to see how this device affects blood flow and pressures in your heart during exercise. Success would mean a change in your peak exercise PCWP (a measure of heart pressure) after 6 months. The current status of this study is unclear, and it plans to enroll 58 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 58 participants.
What's involved
You would have the Barostim™ device implanted and adjusted. Your heart function, symptoms, and exercise ability would be assessed, including measurements of heart pressures during exercise.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at approximately 6 months after the device titration is complete, which is about 7-9 months after implantation.

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

NCT07335510

Impact of Barostimulation on Hemodynamics in Adults With Heart Failure

Recruiting
NAAges 18+InterventionalTreatment
Columbia University
~58 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:Baroreflex Activation Therapy

At a glance

Recruiting sites
1 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in peak exercise PCWP at 6 months post-titration
Measured over Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).

Conditions

HFrEF - Heart Failure With Reduced Ejection Fraction

Explore related trials

Heart Failure

NCT07335510

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Columbia University Irving Medical Center

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Medical University of South Carolina Health

    Charleston, South Carolinastudy coordinator listed

    Not yet recruiting

  • MedStar Health

    Washington D.C., District of Columbiastudy coordinator listed

    Not yet recruiting

  • Montefiore Medical Center

    New York, New Yorkstudy coordinator listed

    Not yet recruiting

  • University of California San Francisco Health

    San Francisco, Californiastudy coordinator listed

    Not yet recruiting

  • University of Chicago Medical Center

    Chicago, Illinoisstudy coordinator listed

    Not yet recruiting

  • Weill Cornell Medicine

    New York, New Yorkstudy coordinator listed

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Nir Uriel, MD · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

Morgan Smith, MD
[email protected]
914-629-3121
Email the study team

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Eligibility criteria

Inclusion

Diagnosis of heart failure with reduced ejection fraction (defined as ejection fraction ≤ 35% for the purposes of this study) (should be within 12 months of screen)
Symptoms consistent with one of:
Laboratories with last N-terminal pro-B-type natriuretic peptide (NT-proBNP) \< 1600 pg/ml (should be within 3 months of screen)
Management with maximally-tolerated GDMT medications and devices
Age \>= 18 years

Exclusion

Age \< 18 years
Myocardial infarction (MI), syncope, cerebrovascular accident (CVA), aborted sudden cardiac death (SCD) (and implantable cardioverter defibrillator (ICD) therapy) within 3 months of screening
Bilateral carotid bifurcations located above the level of the mandible
Carotid artery stenosis greater than 50% caused by atherosclerosis
Ulcerative plaques in the carotid artery
Baroreflex failure or autonomic neuropathy
Symptomatic un-controlled bradyarrhythmias
Severe chronic lung disease
Current treatment with inotropes
Pacemaker or ICD within 3 months of screening
Cardiac resynchronization therapy (CRT) devices within 6 months of screening or anticipated to be placed in the next 90 days following screening
Prior surgery, radiation, endovascular stent in the carotid sinus
History or consideration of solid organ transplantation
History or consideration of left ventricular assist device (LVAD)
Life expectancy \<1 year from time of screening
Non-cardiovascular conditions interfering with 6MWT distance assessment
Inability to fulfill protocol requirements
Known allergy to silicone or titanium

What this trial measures

  • Change in peak exercise PCWP at 6 months post-titrationPre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).

    Exercise pulmonary capillary wedge pressure (PCWP) will be measured at peak exercise at approximately six months post-Barostim titration and compared with peak exercise PCWP measured during the pre-implantation phase. Change from baseline will be calculated.