RecruitingNot ApplicableNCT02827032
Controlling and Lowering Blood Pressure With the MobiusHD™
Controlling and Lowering Blood Pressure With the MobiusHD™ - Defining Efficacy Markers
Sponsor
Vascular Dynamics, Inc.
Enrollment
200 participants
Start Date
Jul 1, 2016
Study Type
INTERVENTIONAL
Conditions
Summary
To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension.
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria1
- 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.
Exclusion Criteria4
- 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
Interventions
DEVICEMobiusHD™
The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
Locations(22)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02827032
Related Trials
EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease
NCT070644731153 locations
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
NCT0605963898 locations
OPtimizing Technology to Improve Medication Adherence and BP Control (OPTIMA-BP)
NCT052937561 location
Coaching and Navigation by Community Health Workers (CHWs) Through Telehealth for High-risk Hypertension
NCT074614154 locations
SGLT2i Improve Left Atrial Function in Patients With Paroxysmal Atrial Fibrillation, Hypertension and Abnormal Glucose Metabolism
NCT074820201 location