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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Berlin, Germany, 12200
        • Withdrawn
        • Charité Berlin
      • Hamburg, Germany
        • Completed
        • Asklepiod Klinik Hamburg
      • Homburg, Germany
        • Completed
        • Universitatsklinikum 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
        • Universitätsklinikum Düsseldorf
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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