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临床试验/NCT02113033
NCT02113033已完成2 期

VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients

LivaNova12 个研究点 分布在 4 个国家目标入组 15 人开始时间: 2014年10月7日最近更新:
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

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

发起方
LivaNova
申办方类型
Industry
责任方
Sponsor

研究点 (12)

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