Hypertension, Resistant Hypertension
Conditions
Keywords
Hypertension, Resistant Hypertension, Baroreceptor, BAT
Brief summary
The objective of this study is to evaluate the safety and effectiveness of the MobiusHD System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal study.
Detailed description
The objective of this study is to evaluate the safety and effectiveness of the MobiusHD System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal study. Patients with resistant hypertension who remain uncontrolled despite pharmacologic treatment with maximum tolerated, guideline-directed anti-hypertensive pharmacologic therapy will be evaluated.
Interventions
DEVICEMobiusHD
The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
OTHERSham Implantation
Sham Implantation
Sponsors
Vascular Dynamics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Mean 24 hour ambulatory systolic blood pressure ≥145 mmHg and ≤200 mmHg and stable for at least 8 weeks on a maximally tolerated guideline directed, (JNC8) or their equivalent when those listed are not available dosing regimen consisting of up to 5 antihypertensive medications, with a minimum required dosing regimen of an A+C+D antihypertensive medication regimen, where A is an angiotensin-converting enzyme Inhibitor or an angiotensin receptor blocker, C is a calcium channel blocker, and D is a diuretic.
Exclusion criteria
* Inadequacy of the carotid anatomy for treatment with the MobiusHD based on carotid angiography.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint - Change in mean 24-hr sABP from baseline to 180-day | 180-day | The primary effectiveness endpoint is change in mean 24-hr ambulatory systolic blood pressure (24hr sABP) from baseline to the 180-day visit. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessments - Composite measured at 90-day | 90-day | Composite measure of death, MI, stroke, device embolization, carotid occlusion, new ipsilateral carotid stenosis requiring surgical or percutaneous intervention, or Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding events as adjudicated by CEC from randomization through the 90-day visit. All adverse events. |
Countries
France, United States
Outcome results
None listed