Impact of Barostimulation on Hemodynamics in Adults With Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Baroreflex Activation Therapy.
- Who it may be relevant to
- Registry conditions: HFrEF - Heart Failure With Reduced Ejection Fraction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Barostimulation in Cardiac Hemodynamics and Clinical Outcomes Through Use of the Barostim™ CVRx Device
Overview
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.
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.
Interventions
- Device Baroreflex Activation Therapy
Barostim™ device (CVRx Inc.), a commercially available, FDA-approved device for autonomic modulation in HFrEF. The device system includes an implantable pulse generator, carotid sinus lead, and programmer system. No investigational modifications will be made. The device will be implanted per standard labeling and programming guidelines, and therapy titration will follow manufacturer recommendations.
Primary outcome measures
- Change in peak exercise PCWP at 6 months post-titration [Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).]
Secondary outcome measures (12)
- Change in peak exercise load-adjusted PCWP at 6 months post-titration [Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).]
- Change in peak exercise output-adjusted PCWP at 6 months post-titration [Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).]
- Change in peak exercise cardiac output at 6 months post-titration [Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).]
- Proportion of participants with significant reduction in PCWP at 6 months post-titration [Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).]
- Change in peak exercise mean PA pressures at 6 months post-titration [Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).]
- Change in peak VO2 at 6 months post-titration [Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).]
- Change in average daily step count [Time frame: Pre-implantation phase (baseline, 0-2 months) and post-implantation phase monthly (approximately 0-9 months post-implantation).]
- Change in average daily step count at 6 months post-titration [Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).]
- Change in highest daily step count at 6 months post-titration [Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).]
- Change in estimated peak VO2 at 6 months post-titration [Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).]
- Change in heart rate variability at 6 months post-titration [Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).]
- Change in proportion of exercise days per month at 6 months post-titration [Time frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).]
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:
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- University of California San Francisco Health — San Francisco
- MedStar Health — Washington D.C.
- University of Chicago Medical Center — Chicago
- Weill Cornell Medicine — New York
- Columbia University Irving Medical Center — New York
- Montefiore Medical Center — New York
- Medical University of South Carolina Health — Charleston
Publications
- Zile MR, Lindenfeld J, Weaver FA, Zannad F, Galle E, Rogers T, Abraham WT. Baroreflex Activation Therapy in Patients With Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2020 Jul 7;76(1):1-13. doi: 10.1016/j.jacc.2020.05.015. PMID 32616150
- Coats AJS, Abraham WT, Zile MR, Lindenfeld JA, Weaver FA, Fudim M, Bauersachs J, Duval S, Galle E, Zannad F. Baroreflex activation therapy with the Barostim device in patients with heart failure with reduced ejection fraction: a patient level meta-analysis of randomized controlled trials. Eur J Heart Fail. 2022 Sep;24(9):1665-1673. doi: 10.1002/ejhf.2573. Epub 2022 Jul 3. PMID 35713888
Identifiers
NCT: NCT07335510 · AAAV9622