Not provided
Not provided
Not provided
Not provided
Not provided
Sponsor decided to not pursue study at this time
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MobiusHD | Experimental | Each subject enrolled in the study will undergo implantation of the MobiusHD® device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MobiusHD | Device | The MobiusHD® device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intradialytic hypotension (IDH) | Incidence of intradialytic hypotension between baseline and 6 months | 6 months |
| Major adverse neurological and cardiovascular events (MANCE) | Incidence of MANCE events between baseline and 6 months | 6 months |
| Change in 44-hour ambulatory blood pressure measurements (ABPM) | Change in 44-hour ABPM between baseline and 6 months | 6 months |
| Change in rate of blood pressure related hospitalizations | Change in rate of blood pressure related hospitalizations between baseline and 6 months | 6 months |
| 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 |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |