Controlling and Lowering Blood Pressure With The MOBIUS HD™ (CALM-FIM_EUR) (CALM-FIM_EUR)

November 20, 2023 updated by: Vascular Dynamics, Inc.

CALM-FIM_EUR - Controlling and Lowering Blood Pressure With the MobiusHD - A Prospective Multicenter Safety Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, multicenter, first-in-man clinical trial to be conducted in Europe. Eligible subjects with stage 2 resistant systemic arterial hypertension currently being treated with a minimum of three (3) anti-hypertensive drugs, who consent to study participation will be assigned to treatment with the MobiusHD system.

Potential study participants will be consented and then screened at two (2) baseline visits beginning at least 30 days prior to MobiusHD placement. Qualified patients will undergo placement of the MobiusHD under angiographic visualization, and will then be followed for 36 months.

Study Type

Interventional

Enrollment (Actual)

30

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

  • Germany
      • Cologne, Germany, 50937
        • University of Cologne
  • Netherlands
      • Nieuwegein, Netherlands, 3430 EM
        • St. Antonius Ziekenhuis
      • Rotterdam, Netherlands, 3015
        • Erasmus Medical Center
      • The Hague, Netherlands, 2545 CH
        • HagaZiekenhuis
      • Utrecht, Netherlands, 3508 GA
        • Universitair Medisch Centrum Utrecht
    • AZ
      • Maastricht, AZ, Netherlands, 6202
        • Maastricht University Medical Center

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Office cuff SBP ≥ 160 mmHg measured per protocol instructions following at least one (1) month of maximally tolerated therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic unless patient has history of intolerance, ineffectiveness or contraindications.

Exclusion Criteria:

  • Known or clinically suspected baroreflex failure or autonomic neuropathy

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MobiusHD
Device: MobiusHD
Implant that is placed in the carotid sinus to control hypertension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: 36 months
The number of participants with serious adverse events reported in the study will be tabulated.
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Systolic Office Cuff Blood Pressure (BP)
Time Frame: Baseline, discharge (up to 2 days), 7 days, 1 month, 3 months, 6 months
Baseline, discharge (up to 2 days), 7 days, 1 month, 3 months, 6 months
Mean 24-hour Systolic Ambulatory Blood Pressure (ABPM) at 6 Months
Time Frame: Baseline, 3 months, 6 months
Baseline, 3 months, 6 months

Collaborators and Investigators

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

Sponsor

Vascular Dynamics, Inc.

Investigators

  • Principal Investigator: Jan Van der Heyden, MD, St. Antonius Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2013

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

February 28, 2020

Study Registration Dates

First Submitted

July 25, 2013

First Submitted That Met QC Criteria

July 26, 2013

First Posted (Estimated)

July 30, 2013

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD0120, CRD0233

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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