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Impact of Barostimulation on Hemodynamics in Adults With Heart Failure

NCT07335510 · Columbia University
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Official title
Impact of Barostimulation in Cardiac Hemodynamics and Clinical Outcomes Through Use of the Barostim™ CVRx Device
About this study
Heart failure with reduced ejection fraction (HFrEF) remains a major public health concern, associated with high rates of morbidity, hospitalizations, and mortality. Despite advances in medication, as well as device therapies such as implantable devices, a significant proportion of patients continue to experience debilitating symptoms, exercise intolerance, and reduced quality of life. An important feature of HFrEF is autonomic imbalance, which contributes to disease progression and adverse outcomes. While current therapies indirectly try to affect this imbalance, the Barostim™ device (CVRx) is the first to specifically target the autonomic nervous system in this population. This device offers a novel mechanistic approach by directly stimulating the carotid baroreceptors to reduce sympathetic activity and restore autonomic balance. This prospective, multicenter study aims to evaluate the effects of the Barostim device on invasive hemodynamics through right heart catheterization (RHC), exercise capacity, and tolerance to medical therapy in HFrEF patients who remain symptomatic despite maximal guideline-directed medical therapy (GDMT). The study seeks to address key knowledge gaps in the mechanistic and clinical response to baroreflex activation therapy (BAT) and inform future integration of this therapy into standard heart failure care.
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
Study design
Enrollment target: 58 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-03-30
Estimated completion: 2028-03
Last updated: 2026-06-29
Interventions
Device: Baroreflex Activation Therapy
Primary outcomes
  • Change in peak exercise PCWP at 6 months post-titration (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).)
Sponsor
Columbia University · other
With: CVRx, Inc.
Contacts & investigators
ContactMorgan Smith, MD · contact · mds2225@cumc.columbia.edu · 914-629-3121
InvestigatorNir Uriel, MD · principal_investigator, Columbia University
All locations (7)
University of California San Francisco HealthNot Yet Recruiting
San Francisco, California, United States
MedStar HealthNot Yet Recruiting
Washington D.C., District of Columbia, United States
University of Chicago Medical CenterNot Yet Recruiting
Chicago, Illinois, United States
Weill Cornell MedicineNot Yet Recruiting
New York, New York, United States
Columbia University Irving Medical CenterRecruiting
New York, New York, United States
Montefiore Medical CenterNot Yet Recruiting
New York, New York, United States
Medical University of South Carolina HealthNot Yet Recruiting
Charleston, South Carolina, United States
Impact of Barostimulation on Hemodynamics in Adults With Heart Failure · TrialPath