Controlling and Lowering Blood Pressure With the MobiusHD™
CALM-DIEM
1 other identifier
interventional
200
3 countries
22
Brief Summary
To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hypertension
Started Jul 2016
Longer than P75 for not_applicable hypertension
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 6, 2016
CompletedFirst Posted
Study publicly available on registry
July 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedOctober 6, 2023
October 1, 2023
8.4 years
July 6, 2016
October 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Incidence of Adverse Events
Baseline to three (3) years post treatment
Other Outcomes (7)
Substudy Outcome Measure - Change in sympathetic activity
Baseline to 90 days post treatment
Substudy Outcome Measure - Change in sympathetic activity
Baseline to 90 days post treatment
Substudy Outcome Measure - Change in sympathetic activity
Baseline to 90 days post treatment
- +4 more other outcomes
Study Arms (1)
MobiusHD™
EXPERIMENTALThe MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
Interventions
The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
Eligibility Criteria
You may qualify 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 qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Universitätsmedizin Mannheim
Mannheim, Baden-Wurttemberg, 68167, Germany
CVC Frankfurt
Frankfurt am Main, Hesse, 60389, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30451, Germany
Uniklinik Köln
Cologne, North Rhine-Westphalia, 50937, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105, Germany
Charite Berlin
Berlin, 12200, Germany
Asklepiod Klinik Hamburg
Hamburg, Germany
Universitatsklinikum des Saarlandes
Homburg, Germany
HagaZiekenhuis
The Hague, AA, 2545, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, EM, 3435, Netherlands
Maastricht UMC+
Maastricht, HX, 6229, Netherlands
Radboud University Medical Center
Nijmegen, 6525GA, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, 3508 GA, Netherlands
Isala
Zwolle, 8025AB, Netherlands
Queen Elizabeth University Hospital - Glasgo
Glasgow, Scotland, G51 4TF, United Kingdom
Golden Jubilee National Hospital
Glasgow, Scotland, G81 4DY, United Kingdom
The Royal Sussex County Hospital
Brighton, BN2 5BE, United Kingdom
St. Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
St. Thomas' Hospital
London, SE1 7EH, United Kingdom
University College London Hospital
London, WC1E 6HX, United Kingdom
Manchester University
Manchester, M13 9PL, United Kingdom
Related Publications (2)
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.
PMID: 37555165DERIVEDvan 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.
PMID: 34784359DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2016
First Posted
July 11, 2016
Study Start
July 1, 2016
Primary Completion
December 1, 2024
Study Completion (Estimated)
June 1, 2026
Last Updated
October 6, 2023
Record last verified: 2023-10