NCT02113033已完成2 期
VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- LivaNova
- 入组人数
- 15
- 试验地点
- 12
- 主要终点
- The primary outcome measure is the freedom from Serious Adverse Device Effects, defined as the number of patients without SADEs.
研究概览
简要总结
The purpose of the VANGUARD study is to demonstrate the safety of Vagal Nerve Stimulation for the treatment of congestive heart failure with reduced ejection fraction, and to report secondary measures of efficacy.
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
- •Left ventricular dysfunction of ischemic or idiopathic dilated cardiomyopathy etiology, characterized by LVEF < 40%
- •Chronic heart failure with symptoms characterized by NYHA functional class II or III at the time of enrollment despite optimal drug regimen
- •Optimal drug regimen as defined in the current European guidelines
- •Sinus rhythm, with spontaneous heart rate ≥ 60bpm at the time of enrollment
- •Signed and dated informed consent
排除标准
- •Patient implanted with or eligible to cardiac pacing as per current guideline
- •Risk for neck surgery in the electrode zone within a year after enrollment
- •Patient with right carotid artery stenosis
- •Symptomatic hypotension
- •History of peptic ulcer disease or upper gastrointestinal bleeding
- •Asthma, severe COPD, or severe restrictive lung disease
- •Advanced Diabetes Mellitus
- •Recent acute myocardial infarction, coronary artery surgery or revascularization (or already planned)
- •Recent cerebro-vascular event
- •Significant valvulopathy
- •Advanced Renal failure
- •Previous heart transplant or current LVAD device therapy
- •Life expectancy < 1 year for non-cardiac cause
- •Patient included in another clinical study that could confound the results of this study
- •Inability to understand the purpose of the study or to perform the procedures of the study
- •Unavailability for scheduled follow-up
- •Age of less than 18 years or under guardianship
- •Pregnancy
研究组 & 干预措施
Treated with Equilia system
Experimental
Implantation and activation of the Vagus Nerve Stimulator, nerve electrode and cardiac lead
干预措施: Equilia® Vagal Nerve Stimulation (Device)
结局指标
主要结局
The primary outcome measure is the freedom from Serious Adverse Device Effects, defined as the number of patients without SADEs.
时间窗: 6 Months
Adverse device effects will be sub-classified into device-related or procedure-related, when the adverse event has a generic cause independent from the device itself and occurs within 30 days of the implant procedure.
次要结局
未报告次要终点
研究者
研究点 (12)
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