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Impact of Barostimulation on Hemodynamics in Adults With Heart Failure

RecruitingNAAges 18 Years - anyAllColumbia University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Baroreflex Activation Therapy
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Where

7 sites
University of California San Francisco Health
San Francisco, United States
MedStar Health
Washington D.C., United States
University of Chicago Medical Center
Chicago, United States
Weill Cornell Medicine
New York, United States
Columbia University Irving Medical Center
New York, United States
Montefiore Medical Center
New York, United States
Medical University of South Carolina Health
Charleston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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