CALM-FIM_EUR - Controlling and Lowering Blood Pressure With the MobiusHD - A Prospective Multicenter Safety Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 12
- 主要终点
- Number of Participants With Serious Adverse Events (SAEs)
研究概览
简要总结
To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.
详细描述
This is an open-label, multicenter, first-in-man clinical trial to be conducted in Europe. Eligible subjects with stage 2 resistant systemic arterial hypertension currently being treated with a minimum of three (3) anti-hypertensive drugs, who consent to study participation will be assigned to treatment with the MobiusHD system.
Potential study participants will be consented and then screened at two (2) baseline visits beginning at least 30 days prior to MobiusHD placement. Qualified patients will undergo placement of the MobiusHD under angiographic visualization, and will then be followed for 36 months.
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
- •Office cuff SBP ≥ 160 mmHg measured per protocol instructions following at least one (1) month of maximally tolerated therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic unless patient has history of intolerance, ineffectiveness or contraindications.
排除标准
- •Known or clinically suspected baroreflex failure or autonomic neuropathy
结局指标
主要结局
Number of Participants With Serious Adverse Events (SAEs)
时间窗: 36 months
The number of participants with serious adverse events reported in the study will be tabulated.
次要结局
- Mean 24-hour Systolic Ambulatory Blood Pressure (ABPM) at 6 Months(Baseline, 3 months, 6 months)
- Systolic Office Cuff Blood Pressure (BP)(Baseline, discharge (up to 2 days), 7 days, 1 month, 3 months, 6 months)