Actively Recruiting
Controlling and Lowering Blood Pressure With the MobiusHD™
Led by Vascular Dynamics, Inc. · Updated on 2023-10-06
200
Participants Needed
22
Research Sites
517 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension.
CONDITIONS
Official Title
Controlling and Lowering Blood Pressure With the MobiusHD™
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Mean 24-hour systolic ABPM of 130 mmHg or higher after at least 30 days on a stable antihypertensive medication regimen
- No changes in medication or dose within 28 days prior to implantation
- Eligible for treatment with the MobiusHD device
- Passed all CALM-DIEM study inclusion and exclusion criteria at time of screening (for substudy participants)
You will not qualify if you...
- Known or clinically suspected baroreflex failure or autonomic neuropathy
- Use of anti-hypertensive drugs directly acting on the sympathetic nervous system that cannot be safely discontinued
- Underlying conditions preventing microneurography, Valsalva maneuver performance, or magnetic resonance imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Universitätsmedizin Mannheim
Mannheim, Baden-Wurttemberg, Germany, 68167
Withdrawn
2
CVC Frankfurt
Frankfurt am Main, Hesse, Germany, 60389
Actively Recruiting
3
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany, 30451
Withdrawn
4
Uniklinik Köln
Cologne, North Rhine-Westphalia, Germany, 50937
Completed
5
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Completed
6
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany, 24105
Withdrawn
7
Charite Berlin
Berlin, Germany, 12200
Withdrawn
8
Asklepiod Klinik Hamburg
Hamburg, Germany
Completed
9
Universitatsklinikum des Saarlandes
Homburg, Germany
Completed
10
HagaZiekenhuis
The Hague, AA, Netherlands, 2545
Completed
11
St. Antonius Ziekenhuis
Nieuwegein, EM, Netherlands, 3435
Completed
12
Maastricht UMC+
Maastricht, HX, Netherlands, 6229
Completed
13
Radboud University Medical Center
Nijmegen, Netherlands, 6525GA
Active, Not Recruiting
14
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands, 3508 GA
Actively Recruiting
15
Isala
Zwolle, Netherlands, 8025AB
Completed
16
Queen Elizabeth University Hospital - Glasgo
Glasgow, Scotland, United Kingdom, G51 4TF
Withdrawn
17
Golden Jubilee National Hospital
Glasgow, Scotland, United Kingdom, G81 4DY
Withdrawn
18
The Royal Sussex County Hospital
Brighton, United Kingdom, BN2 5BE
Withdrawn
19
St. Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Completed
20
St. Thomas' Hospital
London, United Kingdom, SE1 7EH
Withdrawn
21
University College London Hospital
London, United Kingdom, WC1E 6HX
Actively Recruiting
22
Manchester University
Manchester, United Kingdom, M13 9PL
Withdrawn
Research Team
L
Lisa Green
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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