Loading clinical trials...
Loading clinical trials...
CALM-START - Controlling And Lowering Blood Pressure With the MobiusHDTM Device: STudying Effects in A Randomized Trial
To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.
This is a prospective, randomized, double-blind, sham-controlled, multi-center post market study investigating the efficacy and safety of MobiusHD System, and the efficacy of the MobiusHD device in lowering mean systolic 24-hour ABP in subjects with resistant hypertension.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
HagaZiekenhuis
The Hague, AA, Netherlands
Maastricht UMC+
Maastricht, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
UMCU
Utrecht, Netherlands
Start Date
August 24, 2017
Primary Completion Date
June 30, 2021
Completion Date
July 21, 2021
Last Updated
October 10, 2023
4
ACTUAL participants
MobiusHD
DEVICE
Sham Implantation
OTHER
Lead Sponsor
Vascular Dynamics, Inc.
NCT02417740
NCT07073820
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07480265