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Due to the rigorous nature of the trial and enrollment interruptions caused by COVID-19, the study enrolled only 4 of the planned 110 subjects. Due to the lack of enrollment, the study was closed.
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To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.
This is a prospective, randomized, double-blind, sham-controlled, multi-center post market study investigating the efficacy and safety of MobiusHD System, and the efficacy of the MobiusHD device in lowering mean systolic 24-hour ABP in subjects with resistant hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MobiusHD Implantation | Experimental |
| |
| Sham Implantation | Sham Comparator | Sham |
|
| 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 |
|---|---|---|
| The change in mean systolic 24-hour ABP from baseline to 90 days post-randomization, between the treatment arm and the sham arm. | Reduction in mean systolic 24-hour ABP | From Baseline to 90 days post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse clinical events, including death, stroke, carotid interventions, and myocardial infarction, from baseline to 30 days post-randomization, between the treatment arm and the sham arm. | Adverse Events | From Baseline to 30 days post-randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilko Spiering, MD | UMC Utrecht | Principal Investigator |
| Jan Van der Heyden, MD | St. Antonius Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HagaZiekenhuis | The Hague | AA | 2545 | Netherlands | ||
| Maastricht UMC+ |
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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 |
|
| Maastricht |
| 6229 |
| Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | 3435 CM | Netherlands |
| UMCU | Utrecht | 3508 GA | Netherlands |