Impact of Barostimulation in Cardiac Hemodynamics and Clinical Outcomes Through Use of the Barostim™ CVRx Device
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 7
- 主要终点
- Change in peak exercise PCWP at 6 months post-titration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Baroreflex Activation Therapy (Device)
结局指标
主要结局
Change in peak exercise PCWP at 6 months post-titration
时间窗: 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).
Exercise pulmonary capillary wedge pressure (PCWP) will be measured at peak exercise at approximately six months post-Barostim titration and compared with peak exercise PCWP measured during the pre-implantation phase. Change from baseline will be calculated.
次要结局
- Change in peak exercise load-adjusted PCWP at 6 months post-titration(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(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(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(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(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(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(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(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(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(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(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(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 six-minute walk test at 6 months post-titration(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 Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 at 6 months post-titration(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 failure medication score at 6 months post-titration(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 N-terminal prohormone of brain natriuretic peptide at 6 months post-titration(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 sleep score at 6 months post-titration(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 failure admissions at 6 months post-titration(Pre-implantation phase (baseline, approximately 0 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).)
研究者
Nir Uriel
Professor of Cardiology
Columbia University