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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MobiusHD Implantation | Experimental | MobiusHD Implantation |
|
| Sham Implantation | Sham Comparator | Sham Implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MobiusHD | Device | The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint - Change in mean 24-hr sABP from baseline to 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. | 180-day |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessments - Composite measured at 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. | 90-day |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bryan Williams, MD | University College, London | Study Chair |
| Gregg Stone, MD | Cardiovascular Research and Education Columbia University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States | ||
| Southern Illinois University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30407514 | Derived | Calhoun DA, Schiffrin EL, Flack JM. Resistant Hypertension: An Update. Am J Hypertens. 2019 Jan 1;32(1):1-3. doi: 10.1093/ajh/hpy156. No abstract available. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Sham Implantation | Other | Sham Implantation |
|
| Springfield |
| Illinois |
| 62702 |
| United States |
| St. Vincent Heart Center of Indiana | Indianapolis | Indiana | 46290 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| CHU Nancy Centre Coeur et Vaisseaux | Nancy | 54035 | France |