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

• Sponsor: Vascular Dynamics, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05352425
• Collaborator: (none)
• Enrollment: 14
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 60
• Patients Per Site: 7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uncontrolled Hypertension	Device: MobiusHD	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study Assessing the Effect of the MobiusHD® Implant in Renal Hemodialysis Subjects Presented With Uncontrolled Hypertension
• Actual Study Start Date: May 31, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MobiusHD Each subject enrolled in the study will undergo implantation of the MobiusHD® device	Device: MobiusHD; The MobiusHD® device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach.

Outcome Measures

Primary Outcome Measures

1. Incidence of intradialytic hypotension (IDH) [6 months]

   Incidence of intradialytic hypotension between baseline and 6 months

2. Major adverse neurological and cardiovascular events (MANCE) [6 months]

   Incidence of MANCE events between baseline and 6 months

3. Change in 44-hour ambulatory blood pressure measurements (ABPM) [6 months]

   Change in 44-hour ABPM between baseline and 6 months

4. Change in rate of blood pressure related hospitalizations [6 months]

   Change in rate of blood pressure related hospitalizations between baseline and 6 months

5. Change in Quality of Life (QoL), assessed by the London Evaluation of Illness (LEVIL) questionnaire [6 months]

   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. Change in Quality of Life (QoL), assessed by the Kidney Disease Quality of Life (KDQOL-36) questionnaire [6 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University	Saint Louis	Missouri	United States	63108
2	London Health Science Center	London		Canada

Sponsors and Collaborators

• Vascular Dynamics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vascular Dynamics, Inc.
• ClinicalTrials.gov Identifier: NCT05352425
• Other Study ID Numbers: CRD0597, CRD0597_CAN
• First Posted: Apr 28, 2022
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Vascular Dynamics, Inc.: Uncontrolled Hypertension; End Stage Renal Disease; MobiusHD
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Jul 19, 2022