An interventional study of MobiusHD™ in Hypertension, sponsored by Vascular Dynamics, Inc.. Recruiting at 22 sites in 3 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-06.
Sponsored by Vascular Dynamics, Inc. · Not applicable, Interventional, and Treatment
To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension.
The CALM-DIEM Trial is an open-label, prospective, multicenter study for patients who have been selected for treatment with the MobiusHD.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's planned enrollment of 200 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Vascular Dynamics, Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Substudy Eligibility Criteria: A maximum of 16 patients will be enrolled in the sub-study at one site (Universitair Medisch Centrum Utrecht)
Inclusion Criteria:
Exclusion Criteria:
The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
Device: MobiusHD™
The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
Evaluation of 24-hour systolic Ambulatory Blood Pressure Measurement (ABPM)
Change in the mean 24-hours systolic Ambulatory Blood Pressure
Time frame: Baseline to ninety (90) days post treatment
Incidence of Adverse Events
Incidence of SAEs and UADEs reported from implantation through three years post treatment
Time frame: Baseline to three (3) years post treatment
Substudy Outcome Measure - Change in sympathetic activity
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
Time frame: Baseline to 90 days post treatment
Substudy Outcome Measure - Change in sympathetic activity
Change in Blood Oxygen Level Dependent (BOLD) activity of central sympathetic nerve circuits (connectivity of the salience network) measured by resting state BOLD fMRI
Time frame: Baseline to 90 days post treatment
Substudy Outcome Measure - Change in sympathetic activity
Change in Blood Oxygen Level Dependent (BOLD) activity of central sympathetic nerve circuits (brain(stem) response during the Valsalva maneuver) measured by task-based BOLD fMRI
Time frame: Baseline to 90 days post treatment
Substudy Outcome Measure - Change in baroreflex sensitivity
Change sympathetic baroreflex sensitivity (change in muscle sympathetic nerve activity per mmHg blood pressure change) during spontaneous blood pressure fluctuations
Time frame: Baseline to 90 days post treatment
Substudy Outcome Measure - Change in baroreflex sensitivity
Change in sympathetic baroreflex sensitivity (change in muscle sympathetic nerve activity per mmHg blood pressure change) during blood pressure changes evoked by the Valsalva maneuver
Time frame: Baseline to 90 days post treatment
Substudy Outcome Measure - Change in baroreflex sensitivity
Change in cardiac baroreflex sensitivity (change in heartbeat interval per mmHg blood pressure change) during spontaneous blood pressure fluctuations
Time frame: Baseline to 90 days post treatment
Substudy Outcome Measure - Change in baroreflex sensitivity
Change in cardiac baroreflex sensitivity (change in heartbeat interval per mmHg blood pressure change) during blood pressure changes evoked by the Valsalva maneuver
Time frame: Baseline to 90 days post treatment
Plan to share: Undecided
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Vascular Dynamics, Inc.