Hypertension
Conditions
Keywords
Hypertension
Brief summary
To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension.
Detailed description
The CALM-DIEM Trial is an open-label, prospective, multicenter study for patients who have been selected for treatment with the MobiusHD.
Interventions
DEVICEMobiusHD™
The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
Sponsors
Vascular Dynamics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of 24-hour systolic Ambulatory Blood Pressure Measurement (ABPM) | Baseline to ninety (90) days post treatment | Change in the mean 24-hours systolic Ambulatory Blood Pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | Baseline to three (3) years post treatment | Incidence of SAEs and UADEs reported from implantation through three years post treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Substudy Outcome Measure - Change in sympathetic activity | Baseline to 90 days post treatment | Change in muscle sympathetic nerve activity (burst frequency \[bursts/min\] and burst incidence \[burst/100 heartbeats\]) measured by microneurography, from baseline to 90 days post treatment |
| Substudy Outcome Measure - Change in baroreflex sensitivity | Baseline to 90 days post treatment | Change sympathetic baroreflex sensitivity (change in muscle sympathetic nerve activity per mmHg blood pressure change) during spontaneous blood pressure fluctuations |
Countries
Germany, Netherlands, United Kingdom
Contacts
Primary ContactLisa Green
Outcome results
None listed