Impact of Barostimulation on Hemodynamics in Adults With Heart Failure
Recruiting · NCT07335510 · Interventional (participants receive a specific treatment) · Lead sponsor: Columbia University
View the official record on ClinicalTrials.gov →Interventions studied
Baroreflex Activation Therapy
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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:
- 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 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
Where it is running
7 locations listed across 5 US states.
- University of California San Francisco Health - San Francisco, California, United States
- MedStar Health - Washington D.C., District of Columbia, United States
- University of Chicago Medical Center - Chicago, Illinois, United States
- Weill Cornell Medicine - New York, New York, United States
- Columbia University Irving Medical Center - New York, New York, United States
- Montefiore Medical Center - New York, New York, United States
- Medical University of South Carolina Health - Charleston, South Carolina, United States