NCT00718939已完成不适用
Rheos® Diastolic Heart Failure Trial
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
- 6
- 试验地点
- 7
- 主要终点
- Assess left ventricular mass index (LVMI).
研究概览
简要总结
The CVRx® Rheos® Diastolic Heart Failure Trial is a prospective, randomized, double blind trial with up to 60 subjects conducted at up to five centers in Europe. All subjects will be followed up to one year post implant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Be at least 21 years of age.
- •Have bilateral carotid bifurcations that are below the level of the mandible.
- •Have a left ventricular ejection fraction ≥ 45%.
- •Clinical Heart Failure with elevated BNP or NT-Pro-BNP.
排除标准
- •History of or suspected baroreflex failure or autonomic neuropathy.
- •History of symptomatic bradyarrhythmias, pericardial constriction, infiltrative cardiomyopathy, cardiac valvular disease.
- •Organ or hematologic transplant.
- •History of prior surgery, radiation, or stent placement in carotid sinus region.
- •History of severe chronic kidney disease.
- •Life expectancy to less than one year.
结局指标
主要结局
Assess left ventricular mass index (LVMI).
时间窗: at six months post- randomization.
Assess safety by evaluating all adverse events.
时间窗: through six months post -implant
次要结局
- To assess difference between randomization groups in blood pressure changes, blood levels and quality of life.(six months post-implant)
研究者
研究点 (7)
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