Impact of Barostimulation on Hemodynamics in Adults With Heart Failure

Recruiting now · Not applicable

Conditions studied: HFrEF - Heart Failure With Reduced Ejection Fraction

In brief

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.

Key facts

Study ID

NCT07335510

Run by

Columbia University

People needed

58

Starts

2026-03-30

Expected to finish

2028-03-01

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• current New York Heart Association (NYHA) Class III or
• 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

You may not qualify if…

• 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

Where it is running

• Columbia University Irving Medical Center — New York, New York, United States (enrolling)
• MedStar Health — Washington D.C., District of Columbia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• University of California San Francisco Health — San Francisco, California, United States
• Montefiore Medical Center — New York, New York, United States
• Medical University of South Carolina Health — Charleston, South Carolina, United States
• Weill Cornell Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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