NCT01484288已完成不适用
Baroreflex Activation Therapy in Heart Failure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CVRx, Inc.
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Changes in Sympathetic Nervous System Activity (MSNA Bursts/Min)
研究概览
简要总结
The purpose of this clinical investigation is to evaluate the efficacy and safety of the CVRx Barostim Neo System in the treatment of patients with heart failure.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at least 21 years
- •Symptomatic heart failure despite optimal, stable pharmacological therapy for at least 4 weeks
排除标准
- •Significant carotid plaque or stenosis
- •Known or suspected baroreflex failure or autonomic neuropathy
- •Myocardial infarction, unstable angina, syncope, cerebral vascular accident, SCD, or received defibrillation therapy within the past 3 months
- •Heart failure secondary to a reversible condition
结局指标
主要结局
Changes in Sympathetic Nervous System Activity (MSNA Bursts/Min)
时间窗: 6 months
Change in muscle sympathetic nerve activity (MSNA) in bursts/min at 6 months compared to baseline
Changes in Sympathetic Nervous System Activity (MSNA Bursts/100 Heartbeats)
时间窗: 6 months
Changes in Muscle Sympathetic Nerve Activity (bursts/100 heartbeats) at 6 months compared to baseline
次要结局
- Change in Diastolic Blood Pressure(6 months)
- Change in Heart Rate(6 months)
- Change in Six-Minute Hall Walk(6 months)
- Change in Left Ventricular Ejection Fraction (LVEF)(Six months)
- New York Heart Association (NYHA) Class(Six months)
- Change in Systolic Blood Pressure(6 months)
- Change in Quality of Life (Minnesota Living With Heart Failure Questionnaire)(Six months)
研究者
研究点 (1)
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