Uncontrolled Hypertension
Conditions
Keywords
Uncontrolled Hypertension, End Stage Renal Disease, MobiusHD
Brief summary
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
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.
Interventions
DEVICEMobiusHD
The MobiusHD® device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach.
Sponsors
Vascular Dynamics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intradialytic hypotension (IDH) | 6 months | Incidence of intradialytic hypotension between baseline and 6 months |
| Major adverse neurological and cardiovascular events (MANCE) | 6 months | Incidence of MANCE events between baseline and 6 months |
| Change in 44-hour ambulatory blood pressure measurements (ABPM) | 6 months | Change in 44-hour ABPM between baseline and 6 months |
| Change in rate of blood pressure related hospitalizations | 6 months | Change in rate of blood pressure related hospitalizations between baseline and 6 months |
| Change in Quality of Life (QoL), assessed by the London Evaluation of Illness (LEVIL) questionnaire | 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 Quality of Life (QoL), assessed by the Kidney Disease Quality of Life (KDQOL-36) questionnaire | 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. |
Outcome results
None listed