Controlling and Lowering Blood Pressure With the MobiusHD™
To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension.
| Condition(s) | Hypertension |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension. |
| Who can participate | Inclusion Criteria: * Mean 24-hour systolic ABPM is ≥130 mmHg following at least 30 days on a stable antihypertensive medication regimen (no changes in medication or dose), and no more than 28 days prior to implantation. Exclusion Criteria: * Known or clinically suspected baroreflex failure or autonomic neuropathy Substudy Eligibility Criteria: A maximum of 16 patients will be enrolled in the sub-study at one site (Universitair Medisch Centrum Utrecht) Inclusion Criteria: \- Patients must be eligible for the main study and must have passed all CALM-DIEM study inclusion and exclusion criteria at time of screening Exclusion Criteria: * Use of anti-hypertensive drugs directly acting on the sympathetic nervous system that cannot be discontinued safely * Underlying conditions that prohibit micr |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Vascular Dynamics, Inc. |
| Locations | Mannheim, Baden-Wurttemberg, Germany; Frankfurt am Main, Hesse, Germany; Hanover, Lower Saxony, Germany; Cologne, North Rhine-Westphalia, Germany; Düsseldorf, North Rhine-Westphalia, Germany; Kiel, Schleswig-Holstein, Germany (+16 more sites) |
| Start date | 2016-07 |
| NCT ID | NCT02827032 |
| Official listing | https://clinicaltrials.gov/study/NCT02827032 |