Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Controlling And Lowering Blood Pressure With the MobiusHDTM Device (CALM-START)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02804087
Recruitment Status : Active, not recruiting
First Posted : June 17, 2016
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Vascular Dynamics, Inc.

Brief Summary:
To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.

Condition or disease Intervention/treatment Phase
Hypertension Device: MobiusHD Other: Sham Implantation Not Applicable

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CALM-START - Controlling And Lowering Blood Pressure With the MobiusHDTM Device: STudying Effects in A Randomized Trial
Actual Study Start Date : August 24, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MobiusHD Implantation Device: MobiusHD
The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.

Sham Comparator: Sham Implantation
Sham
Other: Sham Implantation
Sham Implantation




Primary Outcome Measures :
  1. The difference in the change in mean systolic 24-hour ABP from baseline to 90 days post-randomization, between the treatment arm and the sham arm. [ Time Frame: From Baseline to 90 days post-randomization ]

Secondary Outcome Measures :
  1. The difference in the number of major adverse clinical events, including death, stroke, carotid interventions, and myocardial infarction, from baseline to 30 days post-randomization, between the treatment arm and the sham arm. [ Time Frame: From Baseline to 30 days post-randomization ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18-70 years;
  • Diagnosed with resistant hypertension;
  • A mean systolic 24-hour ABP of 135-170 mmHg following at least 30 days on a stable antihypertensive medication regimen (no changes in medications or dose).
  • A mean systolic 24-hour ABP of 135-170 mmHg after washout of all antihypertensive medications.

Exclusion Criteria:

  • Known or clinically suspected baroreflex failure or autonomic neuropathy
  • Treatable cause of resistant hypertension
  • Hypertension secondary to an identifiable and treatable cause other than sleep apnea

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804087


Locations
Layout table for location information
Netherlands
HagaZiekenhuis
The Hague, AA, Netherlands, 2545
Maastricht UMC+
Maastricht, Netherlands, 6229
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435 CM
UMCU
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
Vascular Dynamics, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Wilko Spiering, MD UMC Utrecht
Principal Investigator: Jan Van der Heyden, MD St. Antonius Hospital
Layout table for additonal information
Responsible Party: Vascular Dynamics, Inc.
ClinicalTrials.gov Identifier: NCT02804087    
Other Study ID Numbers: CRD0339
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases