NCT02827032招募中不适用
Controlling and Lowering Blood Pressure With the MobiusHD™ - Defining Efficacy Markers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 42
- 主要终点
- Evaluation of 24-hour systolic Ambulatory Blood Pressure Measurement (ABPM)
研究概览
简要总结
To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension.
详细描述
The CALM-DIEM Trial is an open-label, prospective, multicenter study for patients who have been selected for treatment with the MobiusHD.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mean 24-hour systolic ABPM is ≥130 mmHg following at least 30 days on a stable antihypertensive medication regimen (no changes in medication or dose), and no more than 28 days prior to implantation.
排除标准
- •Known or clinically suspected baroreflex failure or autonomic neuropathy
- •Substudy Eligibility Criteria: A maximum of 16 patients will be enrolled in the sub-study at one site (Universitair Medisch Centrum Utrecht)
- •Inclusion Criteria:
- •Patients must be eligible for the main study and must have passed all CALM-DIEM study inclusion and exclusion criteria at time of screening
- •Exclusion Criteria:
- •Use of anti-hypertensive drugs directly acting on the sympathetic nervous system that cannot be discontinued safely
- •Underlying conditions that prohibit microneurography, performance of a Valsalva maneuver and/or magnetic resonance imaging
结局指标
主要结局
Evaluation of 24-hour systolic Ambulatory Blood Pressure Measurement (ABPM)
时间窗: Baseline to ninety (90) days post treatment
Change in the mean 24-hours systolic Ambulatory Blood Pressure
次要结局
- Incidence of Adverse Events(Baseline to three (3) years post treatment)
研究者
研究点 (42)
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