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Impact of Barostimulation on Hemodynamics in Adults With Heart Failure

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how placing and adjusting the CVRx Barostim device affects adults with heart failure whose hearts pump poorly. It looks at heart function, symptoms, ability to exercise, and blood flow and heart pressures during exercise. It is for people already receiving the highest doses of recommended medicines they can tolerate and recommended device treatments.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Heart failure with an ejection fraction of 35% or less, measured within 12 months of screening. This means the heart pumps out 35% or less of its blood with each beat.
  • Heart failure symptoms that greatly limit activity (NYHA Class III), or symptoms that mildly limit activity (Class II) with Class III symptoms in the past.
  • An NT-proBNP blood test result below 1,600 pg/mL within 3 months of screening. This test measures a sign of heart strain.
  • Receiving recommended heart failure medicines at the highest doses you can tolerate, along with recommended device treatments.

Who can't join

  • Under age 18; or a heart attack, fainting, stroke, survived sudden cardiac arrest, or treatment delivered by an implanted defibrillator within 3 months of screening.
  • Both neck arteries split above the jaw; a neck artery is more than 50% narrowed by fatty buildup; or fatty buildup in a neck artery has open sores.
  • Problems with the body's automatic blood pressure control or the nerves that control automatic body functions; uncontrolled slow heart rhythms that cause symptoms; or severe long-term lung disease.
  • Current use of medicines called inotropes to help the heart pump harder; a pacemaker or implanted defibrillator placed within 3 months; or a device to help heart chambers beat together placed within 6 months or planned within 90 days after screening.
  • Past surgery, radiation, or a stent in the carotid sinus, the blood pressure-sensing area of a neck artery; or a known allergy to silicone or titanium.
  • Past or possible organ transplant; or past or possible use of an LVAD, a pump that helps the heart move blood.
  • Expected to live less than 1 year from screening.
  • A condition not related to the heart or blood vessels that affects the 6-minute walk test; or inability to meet study requirements.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (7)

CA

DC

IL

NY

SC