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

October 4, 2023 updated by: Vascular Dynamics, Inc.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6229
        • Maastricht UMC+
      • Nieuwegein, Netherlands, 3435 CM
        • St. Antonius ziekenhuis
      • Utrecht, Netherlands, 3508 GA
        • UMCU
    • AA
      • The Hague, AA, Netherlands, 2545
        • HagaZiekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Reduction in mean systolic 24-hour ABP
From Baseline to 90 days post-randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Adverse Events
From Baseline to 30 days post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vascular Dynamics, Inc.

Investigators

  • Principal Investigator: Wilko Spiering, MD, UMC Utrecht
  • Principal Investigator: Jan Van der Heyden, MD, St. Antonius Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2017

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

July 21, 2021

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimated)

June 17, 2016

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD0339

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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