Barostim Device and Heart Function in Adults With Heart Failure With Reduced Ejection Fraction
Tests the Barostim device's effects on heart function in adults with heart failure.
Plain-language title generated from the registry record
Registry title: Impact of Barostimulation on Hemodynamics in Adults With Heart Failure
Key facts
- Where
- Charleston, Chicago, New York, San Francisco, and Washington D.C., United StatesSee the 7 sites
Where in United States
- Medical University of South Carolina HealthCharleston, United StatesNot yet recruiting
- University of Chicago Medical CenterChicago, United StatesNot yet recruiting
- Columbia University Irving Medical CenterNew York, United StatesTaking people
- Montefiore Medical CenterNew York, United StatesNot yet recruiting
- Weill Cornell MedicineNew York, United StatesNot yet recruiting
- University of California San Francisco HealthSan Francisco, United StatesNot yet recruiting
- MedStar HealthWashington D.C., United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Columbia University
- Trial code
- NCT07335510
- Record updated
- 29 June 2026
- Original description
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.Read full original descriptionShow less
Impact of Barostimulation in Cardiac Hemodynamics and Clinical Outcomes Through Use of the Barostim™ CVRx Device
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.
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:; 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.
Exclusion: Current treatment with inotropes; Prior surgery, radiation, endovascular stent in the carotid sinus; History or consideration of solid organ transplantation; Myocardial infarction (MI), syncope, cerebrovascular accident (CVA), aborted sudden cardiac death (SCD) (and implantable cardioverter defibrillator (ICD) therapy) within 3 months of screening; Baroreflex failure or autonomic neuropathy; Severe chronic lung disease; Cardiac resynchronization therapy (CRT) devices within 6 months of screening or anticipated to be placed in the next 90 days following screening; Non-cardiovascular conditions interfering with 6MWT distance assessment; Known allergy to silicone or titanium; Age < 18 years; 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; Symptomatic un-controlled bradyarrhythmias; Pacemaker or ICD within 3 months of screening; History or consideration of left ventricular assist device (LVAD); Life expectancy <1 year from time of screening; Inability to fulfill protocol requirements.