A Study Assessing the Effect of the MobiusHD® Implant in Renal Hemodialysis Subjects Presented With Uncontrolled Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Incidence of intradialytic hypotension (IDH)
研究概览
简要总结
This is a prospective, multi-center, open-label clinical trial intended to evaluate the safety and benefit of the MobiusHD® system in renal hemodialysis subjects with uncontrolled hypertension.
详细描述
Renal hemodialysis patients with uncontrolled hypertension will be considered for the study. Subjects who meet initial screening requirements will undergo non-invasive imaging of the carotid anatomy to assess adequacy of the anatomy to allow placement of the MobiusHD® device. Eligible subjects will receive an implant placed in the internal carotid artery.
Following implantation of the device, subjects will be followed for 60 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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 years or above
- •End Stage Renal Disease subjects receiving renal hemodialysis at least 3 months prior to procedure
- •Hypertension that is unresponsive to medical therapy of at least 3 anti-hypertensive medication classes
- •Deemed an acceptable candidate for the implant procedure by the investigator
- •Adequacy of the carotid anatomy for treatment with the MobiusHD implant based on non-invasive carotid duplex and CTA imaging, and invasive carotid angiography
排除标准
- •Known or clinically suspected baroreflex failure or autonomic neuropathy
- •History of intradialytic hypotension within the past 3 months
- •Secondary cause of hypertension except treated obstructive sleep apnea syndrome
- •BMI ≥ 45 kg/m2
- •Presence of atherosclerotic plaque in the intended side for implantation as determined by carotid duplex
研究组 & 干预措施
MobiusHD
Each subject enrolled in the study will undergo implantation of the MobiusHD® device
干预措施: MobiusHD (Device)
结局指标
主要结局
Incidence of intradialytic hypotension (IDH)
时间窗: 6 months
Incidence of intradialytic hypotension between baseline and 6 months
Change in Quality of Life (QoL), assessed by the London Evaluation of Illness (LEVIL) questionnaire
时间窗: 6 months
Changes in the London Evaluation of Illness (LEVIL) questionnaire between baseline and 6 months. The scores on the LEVIL range from 0 to 100 Units on a Scale. A higher unit score indicates a better outcome.
Change in 44-hour ambulatory blood pressure measurements (ABPM)
时间窗: 6 months
Change in 44-hour ABPM between baseline and 6 months
Change in rate of blood pressure related hospitalizations
时间窗: 6 months
Change in rate of blood pressure related hospitalizations between baseline and 6 months
Change in Quality of Life (QoL), assessed by the Kidney Disease Quality of Life (KDQOL-36) questionnaire
时间窗: 6 months
Changes in the Kidney Disease Quality of Life (KDQOL-36) questionnaire between baseline and 6 months. The KDQOL-36 compares patients to others of the same age, gender, and diabetes status and is measured on by Units on a Scale. The higher a patient's average is above the mean indicates a better outcome.
Major adverse neurological and cardiovascular events (MANCE)
时间窗: 6 months
Incidence of MANCE events between baseline and 6 months
次要结局
未报告次要终点