Lowering blood pressure with the MobiusHD device
Controlling and Lowering Blood Pressure With the MobiusHD™ - Defining Efficacy Markers
This study is testing whether the MobiusHD device can help people with hard-to-treat high blood pressure manage their condition better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Vascular Dynamics, Inc. Industry-sponsored |
| Locations | 22 sites (Mannheim, Baden-Wurttemberg and 21 other locations) |
| Trial ID | NCT02827032 on ClinicalTrials.gov |
What this trial studies
This study evaluates the performance of the MobiusHD System in patients with primary resistant hypertension. It is an open-label, prospective, multicenter trial designed to gather data on the effectiveness of this device in controlling blood pressure. Participants must have been on a stable antihypertensive medication regimen prior to enrollment. The study aims to provide insights into the long-term management of hypertension using this innovative technology.
Who should consider this trial
Good fit: Ideal candidates are adults with primary resistant hypertension who have not achieved adequate blood pressure control despite stable antihypertensive medication.
Not a fit: Patients with known baroreflex failure or autonomic neuropathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a new treatment option for patients with resistant hypertension, potentially improving their blood pressure control.
How similar studies have performed: Other studies have explored similar interventions for hypertension, but the MobiusHD approach is relatively novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 microneurography, performance of a Valsalva maneuver and/or magnetic resonance imaging
Where this trial is running
Mannheim, Baden-Wurttemberg and 21 other locations
- Universitätsmedizin Mannheim — Mannheim, Baden-Wurttemberg, Germany (Withdrawn)
- CVC Frankfurt — Frankfurt am Main, Hesse, Germany (Recruiting)
- Medizinische Hochschule Hannover — Hanover, Lower Saxony, Germany (Withdrawn)
- Uniklinik Köln — Cologne, North Rhine-Westphalia, Germany (Completed)
- Universitätsklinikum Düsseldorf — Düsseldorf, North Rhine-Westphalia, Germany (Completed)
- Universitätsklinikum Schleswig-Holstein — Kiel, Schleswig-Holstein, Germany (Withdrawn)
- Charite Berlin — Berlin, Germany (Withdrawn)
- Asklepiod Klinik Hamburg — Hamburg, Germany (Completed)
- Universitatsklinikum des Saarlandes — Homburg, Germany (Completed)
- HagaZiekenhuis — The Hague, Aa, Netherlands (Completed)
- St. Antonius Ziekenhuis — Nieuwegein, Em, Netherlands (Completed)
- Maastricht UMC+ — Maastricht, Hx, Netherlands (Completed)
- Radboud University Medical Center — Nijmegen, Netherlands (Active_not_recruiting)
- Universitair Medisch Centrum Utrecht — Utrecht, Netherlands (Recruiting)
- Isala — Zwolle, Netherlands (Completed)
- Queen Elizabeth University Hospital - Glasgo — Glasgow, Scotland, United Kingdom (Withdrawn)
- Golden Jubilee National Hospital — Glasgow, Scotland, United Kingdom (Withdrawn)
- The Royal Sussex County Hospital — Brighton, United Kingdom (Withdrawn)
- St. Bartholomew's Hospital — London, United Kingdom (Completed)
- St. Thomas' Hospital — London, United Kingdom (Withdrawn)
- University College London Hospital — London, United Kingdom (Recruiting)
- Manchester University — Manchester, United Kingdom (Withdrawn)
Study contacts
- Study coordinator: Lisa Green
- Email: lgreen@vasculardynamics.com
- Phone: 949.231.7602
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.