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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Uncontrolled Hypertension
• Intervention / Treatment: Device: MobiusHD

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vascular Dynamics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Actual): October 10, 2022
• Study Completion (Actual): October 10, 2022

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: End Stage Renal Disease; Uncontrolled Hypertension; MobiusHD
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: CRD0597, CRD0597_CAN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes