Impact of Barostimulation on Hemodynamics in Adults With Heart Failure
Purpose
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.
Condition
- HFrEF - Heart Failure With Reduced Ejection Fraction
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- This is a single-group, self-controlled study in which all enrolled participants receive the same intervention. Outcomes are evaluated within participants using pre- and post-implantation assessments following Barostim device implantation and titration.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Barostim™ Therapy |
Participants will undergo implantation of the Barostim™ system, followed by device programming and titration according to standard clinical practice for up to three months after implantation. |
|
Recruiting Locations
New York, New York 10032
More Details
- Status
- Recruiting
- Sponsor
- Columbia University
Detailed Description
Heart failure with reduced ejection fraction (HFrEF) remains a major public health concern, associated with high rates of morbidity, hospitalizations, and mortality. Despite advances in medication, as well as device therapies such as implantable devices, a significant proportion of patients continue to experience debilitating symptoms, exercise intolerance, and reduced quality of life. An important feature of HFrEF is autonomic imbalance, which contributes to disease progression and adverse outcomes. While current therapies indirectly try to affect this imbalance, the Barostim™ device (CVRx) is the first to specifically target the autonomic nervous system in this population. This device offers a novel mechanistic approach by directly stimulating the carotid baroreceptors to reduce sympathetic activity and restore autonomic balance. This prospective, multicenter study aims to evaluate the effects of the Barostim device on invasive hemodynamics through right heart catheterization (RHC), exercise capacity, and tolerance to medical therapy in HFrEF patients who remain symptomatic despite maximal guideline-directed medical therapy (GDMT). The study seeks to address key knowledge gaps in the mechanistic and clinical response to baroreflex activation therapy (BAT) and inform future integration of this therapy into standard heart failure care.