Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT02827032

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

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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Withdrawn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Withdrawn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Withdrawn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Withdrawn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

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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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Controlling and Lowering Blood Pressure With the MobiusHD™ | DecenTrialz