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

Uncontrolled Hypertension Clinical Trial

— HD  

Official title:

A Study Assessing the Effect of the MobiusHD® Implant in Renal Hemodialysis Subjects Presented With Uncontrolled Hypertension

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05352425
• Other study ID #: CRD0597, CRD0597_CAN
• Status: Withdrawn
• Phase: N/A
• Start date: May 31, 2022
• Est. completion date: October 10, 2022

Study information

• Verified date: May 2023
• Source: Vascular Dynamics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 10, 2022
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Uncontrolled Hypertension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Dynamics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of intradialytic hypotension (IDH)	Incidence of intradialytic hypotension between baseline and 6 months	6 months
Primary	Major adverse neurological and cardiovascular events (MANCE)	Incidence of MANCE events between baseline and 6 months	6 months
Primary	Change in 44-hour ambulatory blood pressure measurements (ABPM)	Change in 44-hour ABPM between baseline and 6 months	6 months
Primary	Change in rate of blood pressure related hospitalizations	Change in rate of blood pressure related hospitalizations between baseline and 6 months	6 months
Primary	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
Primary	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