NL-OMON38362已完成3 期
Rheos(TM) Pivotal Trial, a Study of Baroreflex Hypertension Therapy in Refractory Hypertension. Amendment 1: Dynamic cerebral autoregulation and lacol pulsewave velocity. Amendment 2: Investigational Plan , revision D Amendment 3: Investigational Plan, revision E Amendment 4: Investigational Plan, revision F - Rheos(TM) Pivotal Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CVRx Inc
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Ten minste 21 jaar en niet ouder dan 80 jaar
- •Office blood pressure equal or above 160/80 mmHg
- •Ambulatory 24-hour systolic blood pressure equal or above 135 mmHg
- •Normal anatomy of carotid artery bifurcations
- •Full doses of anti-hypertensive treatment (3 medication with 1 diuretic)
- •Compliant to therapy
- •Not pregnant or contemplating pregnancy during study period
排除标准
- •Known or suspected baroreflex failure or autonomic neuropathy
- •Body Mass Index above 45
- •Myocardial infarction, unstable angina, syncope or CVA within the past 3 months
- •Carotid atherosclerosis producing a 50% or greater reduction in diameter
- •Prior surgery, radiation or endobvascular stent placement in carotid sinus region
- •Severe chronic kidney disease, estimated GFR below 30 ml/min
研究者
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