NCT01885390已完成3 期
ROX CONTROL HTN Registry: To Evaluate the ROX Coupler in Patients With Resistant or Uncontrolled Hypertension
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 4
- 主要终点
- Change in ambulatory daytime mean systolic blood pressure
研究概览
简要总结
The purpose of this registry is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant or uncontrolled hypertension.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of resistant or uncontrolled hypertension must be made on the basis of current findings, medical history, and physical examination.
排除标准
- •Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the registry, comply with follow-up requirements, or impact the scientific integrity of the study.
研究组 & 干预措施
Experimental: Group A
Experimental
ROX Coupler + continuing standard antihypertensive medications
干预措施: ROX COUPLER (Device)
结局指标
主要结局
Change in ambulatory daytime mean systolic blood pressure
时间窗: Baseline, 6 months
Change in mean ambulatory daytime systolic blood pressure at six months as compared to Baseline.
次要结局
- Change in ambulatory daytime mean diastolic blood pressure(Baseline, 6 months)
研究者
研究点 (4)
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