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Impact of Barostimulation on Hemodynamics in Adults With Heart Failure

Recruiting

Impact of Barostimulation in Cardiac Hemodynamics and Clinical Outcomes Through Use of the Barostim™ CVRx Device

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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:

  1. current New York Heart Association (NYHA) Class III or
  2. current NYHA Class II and historical NYHA Class III
* 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 Criteria:

* 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

About the study

This study evaluates the effects of the implantation and adjustment of the CVRx Barostim device in adult patients with heart failure with reduced ejection fraction who are receiving maximally tolerated doses of guideline directed medical and device therapies. The study aims to assess how therapy using this device affects heart function, symptoms, and exercise capacity, with particular focus on how the device affects blood flow and heart pressures during exercise. Information from this study may help inform patient selection and device management in patients with heart failure.

What is being tested

Sponsor: Columbia University · Participants: 58 · Started: Mar 30, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07335510

Locations in the U.S.

CaliforniaUniversity of California San Francisco Health, San Francisco (Not yet recruiting)
District of ColumbiaMedStar Health, Washington D.C. (Not yet recruiting)
IllinoisUniversity of Chicago Medical Center, Chicago (Not yet recruiting)
New YorkColumbia University Irving Medical Center, New York
Montefiore Medical Center, New York (Not yet recruiting)
Weill Cornell Medicine, New York (Not yet recruiting)
South CarolinaMedical University of South Carolina Health, Charleston (Not yet recruiting)

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.