Status:
WITHDRAWN
Effect of the MobiusHD® in Renal Hemodialysis Subjects With Uncontrolled Hypertension
Lead Sponsor:
Vascular Dynamics, Inc.
Conditions:
Uncontrolled Hypertension
Eligibility:
All Genders
21+ years
Phase:
NA
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05352425
Start Date
May 31 2022
End Date
October 10 2022
Last Update
May 10 2023
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