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

Not Applicable

Withdrawn

• Conditions: Uncontrolled Hypertension
• Interventions: Device: MobiusHD

• Registration Number: NCT05352425
• Lead Sponsor: Vascular Dynamics, Inc.

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.

Study Timeline

• Study First Submitted: 2022-04-01
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-04-28
• Study Start: 2022-05-31
• Primary Completion: 2022-10-10
• Study Completion: 2022-10-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MobiusHD	MobiusHD	Each subject enrolled in the study will undergo implantation of the MobiusHD® device

Primary Outcome Measures

Name	Time	Method
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 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 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.
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