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

Vascular Dynamics, Inc.

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Uncontrolled Hypertension

Interventions

MobiusHDDEVICE

The MobiusHD® device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 21 years or above 2. End Stage Renal Disease subjects receiving renal hemodialysis at least 3 months prior to procedure 3. Hypertension that is unresponsive to medical therapy of at least 3 anti-hypertensive medication classes 4. Deemed an acceptable candidate for the implant procedure by the investigator 5. 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: 1. Known or clinically suspected baroreflex failure or autonomic neuropathy 2. History of intradialytic hypotension within the past 3 months 3. Secondary cause of hypertension except treated obstructive sleep apnea syndrome 4. BMI ≥ 45 kg/m2 5. Presence of atherosclerotic plaque in the intended side for implantation as determined by carotid duplex

Outcomes

Primary Outcomes

Incidence of intradialytic hypotension (IDH)

Incidence of intradialytic hypotension between baseline and 6 months

Time frame: 6 months

Major adverse neurological and cardiovascular events (MANCE)

Incidence of MANCE events between baseline and 6 months

Time frame: 6 months

Change in 44-hour ambulatory blood pressure measurements (ABPM)

Change in 44-hour ABPM between baseline and 6 months

Time frame: 6 months

Change in rate of blood pressure related hospitalizations

Change in rate of blood pressure related hospitalizations between baseline and 6 months

Time frame: 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.

Time frame: 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.

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.