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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MobiusHD™ | Experimental | The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MobiusHD™ | Device | The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of 24-hour systolic Ambulatory Blood Pressure Measurement (ABPM) | Change in the mean 24-hours systolic Ambulatory Blood Pressure | Baseline to ninety (90) days post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Incidence of SAEs and UADEs reported from implantation through three years post treatment | Baseline to three (3) years post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to 90 days post treatment |
| Substudy Outcome Measure - Change in sympathetic activity |
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:
- 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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Green | Contact | 949.231.7602 | lgreen@vasculardynamics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsmedizin Mannheim | Withdrawn | Mannheim | Baden-Wurttemberg | 68167 | Germany | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37555165 | Derived | Groenland EH, van Kleef MEAM, Hendrikse J, Spiering W, Siero JCW. The effect of endovascular baroreflex amplification on central sympathetic nerve circuits and cerebral blood flow in patients with resistant hypertension: A functional MRI study. Front Neuroimaging. 2022 Jul 25;1:924724. doi: 10.3389/fnimg.2022.924724. eCollection 2022. | |
| 34784359 |
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Change in Blood Oxygen Level Dependent (BOLD) activity of central sympathetic nerve circuits (connectivity of the salience network) measured by resting state BOLD fMRI |
| 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 | 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 | 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 | 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 | 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 | Baseline to 90 days post treatment |
| CVC Frankfurt |
| Recruiting |
| Frankfurt am Main |
| Hesse |
| 60389 |
| Germany |
|
| Medizinische Hochschule Hannover | Withdrawn | Hanover | Lower Saxony | 30451 | Germany |
| Uniklinik Köln | Completed | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Universitätsklinikum Düsseldorf | Completed | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| Universitätsklinikum Schleswig-Holstein | Withdrawn | Kiel | Schleswig-Holstein | 24105 | Germany |
| Charite Berlin | Withdrawn | Berlin | 12200 | Germany |
| Asklepiod Klinik Hamburg | Completed | Hamburg | Germany |
| Universitatsklinikum des Saarlandes | Completed | Homburg | Germany |
| HagaZiekenhuis | Completed | The Hague | AA | 2545 | Netherlands |
| St. Antonius Ziekenhuis | Completed | Nieuwegein | EM | 3435 | Netherlands |
| Maastricht UMC+ | Completed | Maastricht | HX | 6229 | Netherlands |
| Radboud University Medical Center | Active, not recruiting | Nijmegen | 6525GA | Netherlands |
| Universitair Medisch Centrum Utrecht | Recruiting | Utrecht | 3508 GA | Netherlands |
|
| Isala | Completed | Zwolle | 8025AB | Netherlands |
| Queen Elizabeth University Hospital - Glasgo | Withdrawn | Glasgow | Scotland | G51 4TF | United Kingdom |
| Golden Jubilee National Hospital | Withdrawn | Glasgow | Scotland | G81 4DY | United Kingdom |
| The Royal Sussex County Hospital | Withdrawn | Brighton | BN2 5BE | United Kingdom |
| St. Bartholomew's Hospital | Completed | London | EC1A 7BE | United Kingdom |
| St. Thomas' Hospital | Withdrawn | London | SE1 7EH | United Kingdom |
| University College London Hospital | Recruiting | London | WC1E 6HX | United Kingdom |
|
| Manchester University | Withdrawn | Manchester | M13 9PL | United Kingdom |
| van Kleef MEAM, Heusser K, Diedrich A, Oey PL, Tank J, Jordan J, Blankestijn PJ, Williams B, Spiering W. Endovascular baroreflex amplification and the effect on sympathetic nerve activity in patients with resistant hypertension: A proof-of-principle study. PLoS One. 2021 Nov 16;16(11):e0259826. doi: 10.1371/journal.pone.0259826. eCollection 2021. |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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