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

NCT05352425 | Withdrawn DMC FDA Device

• 1 other identifier: CRD0597, CRD0597_CAN
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Uncontrolled Hypertension

Keywords

Uncontrolled Hypertension; End Stage Renal Disease; MobiusHD

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

MobiusHD

EXPERIMENTAL

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

Device: MobiusHD

Interventions

MobiusHD DEVICE

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

MobiusHD

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vascular Dynamics, Inc.: lead

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 28, 2022
• Study Start: May 31, 2022
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05