Controlling and Lowering Blood Pressure With the MobiusHD™

Launched by VASCULAR DYNAMICS, INC. · Jul 6, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a device called the MobiusHD™ System, which aims to help lower blood pressure in people with a condition known as primary resistant hypertension. This means the participants have high blood pressure that hasn't been well controlled by standard medications. The trial is open to all adults aged 65 to 74 and 29 to 219, and it's currently looking for new participants.

To be eligible, individuals must have a specific average blood pressure reading that shows their condition is not well managed, and they should have been on the same blood pressure medications for at least 30 days before joining the study. Participants will receive the MobiusHD™ treatment and will be monitored to see how well it works in controlling their blood pressure. It’s important to note that some people may not be able to participate if they have certain medical conditions or are on specific types of medications that could interfere with the trial.

Gender

ALL

Eligibility 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