Controlling and Lowering Blood Pressure With the MobiusHD™ (CALM-DIEM)

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

Controlling and Lowering Blood Pressure With the MobiusHD™ - Defining Efficacy Markers

To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The CALM-DIEM Trial is an open-label, prospective, multicenter study for patients who have been selected for treatment with the MobiusHD.

Study Type

Interventional

Enrollment (Estimated)

200

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 Contact

Study Locations

  • Germany
      • Berlin, Germany, 12200
        • Withdrawn
        • Charite Berlin
      • Hamburg, Germany
        • Completed
        • Asklepiod Klinik Hamburg
      • Homburg, Germany
        • Completed
        • Universitätsklinikum des Saarlandes
    • Baden-Württemberg
      • Mannheim, Baden-Württemberg, Germany, 68167
        • Withdrawn
        • Universitätsmedizin Mannheim
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60389
        • Recruiting
        • CVC Frankfurt
        • Contact:
        • Principal Investigator:
          • Horst Sievert, MD
    • Lower Saxony
      • Hannover, Lower Saxony, Germany, 30451
        • Withdrawn
        • Medizinische Hochschule Hannover
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Completed
        • Uniklinik Köln
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Completed
        • Universitatsklinikum Dusseldorf
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Withdrawn
        • Universitatsklinikum Schleswig-Holstein
  • Netherlands
      • Nijmegen, Netherlands, 6525GA
        • Active, not recruiting
        • Radboud University Medical Center
      • Utrecht, Netherlands, 3508 GA
        • Recruiting
        • Universitair Medisch Centrum Utrecht
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wilko Spiering, MD, PhD
      • Zwolle, Netherlands, 8025AB
        • Completed
        • Isala
    • AA
      • The Hague, AA, Netherlands, 2545
        • Completed
        • HagaZiekenhuis
    • EM
      • Nieuwegein, EM, Netherlands, 3435
        • Completed
        • St. Antonius Ziekenhuis
    • HX
      • Maastricht, HX, Netherlands, 6229
        • Completed
        • Maastricht UMC+
  • United Kingdom
      • Brighton, United Kingdom, BN2 5BE
        • Withdrawn
        • The Royal Sussex County Hospital
      • London, United Kingdom, EC1A 7BE
        • Completed
        • St. Bartholomew's Hospital
      • London, United Kingdom, SE1 7EH
        • Withdrawn
        • St. Thomas' Hospital
      • London, United Kingdom, WC1E 6HX
        • Recruiting
        • University College London Hospital
        • Contact:
        • Principal Investigator:
          • Bryan Williams
        • Sub-Investigator:
          • Joe Brookes
      • Manchester, United Kingdom, M13 9PL
        • Withdrawn
        • Manchester University
    • Scotland
      • Glasgow, Scotland, United Kingdom, G51 4TF
        • Withdrawn
        • Queen Elizabeth University Hospital - Glasgo
      • Glasgow, Scotland, United Kingdom, G81 4DY
        • Withdrawn
        • Golden Jubilee National Hospital

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:

  • 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 Criteria:

  • 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)

Inclusion Criteria:

- Patients must be eligible for the main study and must have passed all CALM-DIEM study inclusion and exclusion criteria at time of screening

Exclusion Criteria:

  • 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

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™
The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
Device: MobiusHD™
The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of 24-hour systolic Ambulatory Blood Pressure Measurement (ABPM)
Time Frame: Baseline to ninety (90) days post treatment
Change in the mean 24-hours systolic Ambulatory Blood Pressure
Baseline to ninety (90) days post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events
Time Frame: Baseline to three (3) years post treatment
Incidence of SAEs and UADEs reported from implantation through three years post treatment
Baseline to three (3) years post treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Substudy Outcome Measure - Change in sympathetic activity
Time Frame: Baseline to 90 days post treatment
Change in muscle sympathetic nerve activity (burst frequency [bursts/min] and burst incidence [burst/100 heartbeats]) measured by microneurography, from baseline to 90 days post treatment
Baseline to 90 days post treatment
Substudy Outcome Measure - Change in sympathetic activity
Time Frame: Baseline to 90 days post treatment
Change in Blood Oxygen Level Dependent (BOLD) activity of central sympathetic nerve circuits (connectivity of the salience network) measured by resting state BOLD fMRI
Baseline to 90 days post treatment
Substudy Outcome Measure - Change in sympathetic activity
Time Frame: Baseline to 90 days post treatment
Change in Blood Oxygen Level Dependent (BOLD) activity of central sympathetic nerve circuits (brain(stem) response during the Valsalva maneuver) measured by task-based BOLD fMRI
Baseline to 90 days post treatment
Substudy Outcome Measure - Change in baroreflex sensitivity
Time Frame: Baseline to 90 days post treatment
Change sympathetic baroreflex sensitivity (change in muscle sympathetic nerve activity per mmHg blood pressure change) during spontaneous blood pressure fluctuations
Baseline to 90 days post treatment
Substudy Outcome Measure - Change in baroreflex sensitivity
Time Frame: Baseline to 90 days post treatment
Change in sympathetic baroreflex sensitivity (change in muscle sympathetic nerve activity per mmHg blood pressure change) during blood pressure changes evoked by the Valsalva maneuver
Baseline to 90 days post treatment
Substudy Outcome Measure - Change in baroreflex sensitivity
Time Frame: Baseline to 90 days post treatment
Change in cardiac baroreflex sensitivity (change in heartbeat interval per mmHg blood pressure change) during spontaneous blood pressure fluctuations
Baseline to 90 days post treatment
Substudy Outcome Measure - Change in baroreflex sensitivity
Time Frame: Baseline to 90 days post treatment
Change in cardiac baroreflex sensitivity (change in heartbeat interval per mmHg blood pressure change) during blood pressure changes evoked by the Valsalva maneuver
Baseline to 90 days post treatment

Collaborators and Investigators

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

Sponsor

Vascular Dynamics, Inc.

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)

July 1, 2016

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

July 6, 2016

First Submitted That Met QC Criteria

July 6, 2016

First Posted (Estimated)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD0328

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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