The CALM-DIEM Trial is an open-label, prospective, multicenter study for patients who have been selected for treatment with the MobiusHD.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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)
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
Clareo Health | Controlling and Lowering Blood Pressure With the MobiusHD™