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

NCT ID: NCT05352425

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2022-10-10

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.

Conditions

Uncontrolled Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MobiusHD

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

Group Type: EXPERIMENTAL

MobiusHD

Intervention Type: DEVICE

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

Interventions

MobiusHD

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vascular Dynamics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CRD0597, CRD0597_CAN

Identifier Type: -

Identifier Source: org_study_id