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

Vascular Dynamics

Status

Withdrawn

Conditions

Uncontrolled Hypertension

Treatments

Device: MobiusHD

Study type

Interventional

Funder types

Industry

Identifiers

NCT05352425

CRD0597, CRD0597_CAN

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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