Back to resultsEffect of the MobiusHD® in Renal Hemodialysis Subjects With Uncontrolled Hypertension (HD)
Primary Purpose
Uncontrolled Hypertension
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MobiusHD
Sponsored by
About this trial
This is an interventional treatment trial for Uncontrolled Hypertension focused on measuring Uncontrolled Hypertension, End Stage Renal Disease, MobiusHD
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MobiusHD
Arm Description
Each subject enrolled in the study will undergo implantation of the MobiusHD® device
Outcomes
Primary Outcome Measures
Incidence of intradialytic hypotension (IDH)
Incidence of intradialytic hypotension between baseline and 6 months
Major adverse neurological and cardiovascular events (MANCE)
Incidence of MANCE events between baseline and 6 months
Change in 44-hour ambulatory blood pressure measurements (ABPM)
Change in 44-hour ABPM between baseline and 6 months
Change in rate of blood pressure related hospitalizations
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
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05352425
Brief Title
Effect of the MobiusHD® in Renal Hemodialysis Subjects With Uncontrolled Hypertension
Acronym
HD
Official Title
A Study Assessing the Effect of the MobiusHD® Implant in Renal Hemodialysis Subjects Presented With Uncontrolled Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor decided to not pursue study at this time
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
October 10, 2022 (Actual)
Study Completion Date
October 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vascular Dynamics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncontrolled Hypertension
Keywords
Uncontrolled Hypertension, End Stage Renal Disease, MobiusHD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MobiusHD
Arm Type
Experimental
Arm Description
Each subject enrolled in the study will undergo implantation of the MobiusHD® device
Intervention Type
Device
Intervention Name(s)
MobiusHD
Intervention Description
The MobiusHD® device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach.
Primary Outcome Measure Information:
Title
Incidence of intradialytic hypotension (IDH)
Description
Incidence of intradialytic hypotension between baseline and 6 months
Time Frame
6 months
Title
Major adverse neurological and cardiovascular events (MANCE)
Description
Incidence of MANCE events between baseline and 6 months
Time Frame
6 months
Title
Change in 44-hour ambulatory blood pressure measurements (ABPM)
Description
Change in 44-hour ABPM between baseline and 6 months
Time Frame
6 months
Title
Change in rate of blood pressure related hospitalizations
Description
Change in rate of blood pressure related hospitalizations between baseline and 6 months
Time Frame
6 months
Title
Change in Quality of Life (QoL), assessed by the London Evaluation of Illness (LEVIL) questionnaire
Description
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
Title
Change in Quality of Life (QoL), assessed by the Kidney Disease Quality of Life (KDQOL-36) questionnaire
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Effect of the MobiusHD® in Renal Hemodialysis Subjects With Uncontrolled Hypertension
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