Effect of the MobiusHD® in Renal Hemodialysis Subjects With Uncontrolled Hypertension

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Study Assessing the Effect of the MobiusHD® Implant in Renal Hemodialysis Subjects Presented With Uncontrolled Hypertension

Conditions
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Uncontrolled Hypertension

Intervention / Treatment
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* Device: MobiusHD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MobiusHD<br>Each subject enrolled in the study will undergo implantation of the MobiusHD® device | Device: MobiusHD<br>* The MobiusHD® device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intradialytic hypotension (IDH) | Incidence of intradialytic hypotension between baseline and 6 months | 6 months | 
| Major adverse neurological and cardiovascular events (MANCE) | Incidence of MANCE events between baseline and 6 months | 6 months | 
| Change in 44-hour ambulatory blood pressure measurements (ABPM) | Change in 44-hour ABPM between baseline and 6 months | 6 months | 
| Change in rate of blood pressure related hospitalizations | Change in rate of blood pressure related hospitalizations between baseline and 6 months | 6 months | 
| Change in Quality of Life (QoL), assessed by the London Evaluation of Illness (LEVIL) questionnaire | 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. | 6 months | 
| Change in Quality of Life (QoL), assessed by the Kidney Disease Quality of Life (KDQOL-36) questionnaire | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uncontrolled Hypertension, End Stage Renal Disease, MobiusHD