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
- Change in Quality of Life (QoL), assessed by the London Evaluation of Illness (LEVIL) questionnaire
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
结局指标
主要结局
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.
Incidence of intradialytic hypotension (IDH)
时间窗: 6 months
Incidence of intradialytic hypotension between baseline and 6 months
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