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

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MobiusHD™
Sponsored by
Vascular Dynamics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsmedizin Mannheim
  • CVC FrankfurtRecruiting
  • Medizinische Hochschule Hannover
  • Uniklinik Köln
  • Universitätsklinikum Düsseldorf
  • Universitätsklinikum Schleswig-Holstein
  • Charite Berlin
  • Asklepiod Klinik Hamburg
  • Universitatsklinikum des Saarlandes
  • HagaZiekenhuis
  • St. Antonius Ziekenhuis
  • Maastricht UMC+
  • Radboud University Medical Center
  • Universitair Medisch Centrum UtrechtRecruiting
  • Isala
  • Queen Elizabeth University Hospital - Glasgo
  • Golden Jubilee National Hospital
  • The Royal Sussex County Hospital
  • St. Bartholomew's Hospital
  • St. Thomas' Hospital
  • University College London HospitalRecruiting
  • Manchester University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MobiusHD™

Arm Description

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

Outcomes

Primary Outcome Measures

Evaluation of 24-hour systolic Ambulatory Blood Pressure Measurement (ABPM)
Change in the mean 24-hours systolic Ambulatory Blood Pressure

Secondary Outcome Measures

Incidence of Adverse Events
Incidence of SAEs and UADEs reported from implantation through three years post treatment

Full Information

First Posted
July 6, 2016
Last Updated
October 4, 2023
Sponsor
Vascular Dynamics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02827032
Brief Title
Controlling and Lowering Blood Pressure With the MobiusHD™
Acronym
CALM-DIEM
Official Title
Controlling and Lowering Blood Pressure With the MobiusHD™ - Defining Efficacy Markers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vascular Dynamics, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension.
Detailed Description
The CALM-DIEM Trial is an open-label, prospective, multicenter study for patients who have been selected for treatment with the MobiusHD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MobiusHD™
Arm Type
Experimental
Arm Description
The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
Intervention Type
Device
Intervention Name(s)
MobiusHD™
Intervention Description
The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
Primary Outcome Measure Information:
Title
Evaluation of 24-hour systolic Ambulatory Blood Pressure Measurement (ABPM)
Description
Change in the mean 24-hours systolic Ambulatory Blood Pressure
Time Frame
Baseline to ninety (90) days post treatment
Secondary Outcome Measure Information:
Title
Incidence of Adverse Events
Description
Incidence of SAEs and UADEs reported from implantation through three years post treatment
Time Frame
Baseline to three (3) years post treatment
Other Pre-specified Outcome Measures:
Title
Substudy Outcome Measure - Change in sympathetic activity
Description
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
Time Frame
Baseline to 90 days post treatment
Title
Substudy Outcome Measure - Change in sympathetic activity
Description
Change in Blood Oxygen Level Dependent (BOLD) activity of central sympathetic nerve circuits (connectivity of the salience network) measured by resting state BOLD fMRI
Time Frame
Baseline to 90 days post treatment
Title
Substudy Outcome Measure - Change in sympathetic activity
Description
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
Time Frame
Baseline to 90 days post treatment
Title
Substudy Outcome Measure - Change in baroreflex sensitivity
Description
Change sympathetic baroreflex sensitivity (change in muscle sympathetic nerve activity per mmHg blood pressure change) during spontaneous blood pressure fluctuations
Time Frame
Baseline to 90 days post treatment
Title
Substudy Outcome Measure - Change in baroreflex sensitivity
Description
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
Time Frame
Baseline to 90 days post treatment
Title
Substudy Outcome Measure - Change in baroreflex sensitivity
Description
Change in cardiac baroreflex sensitivity (change in heartbeat interval per mmHg blood pressure change) during spontaneous blood pressure fluctuations
Time Frame
Baseline to 90 days post treatment
Title
Substudy Outcome Measure - Change in baroreflex sensitivity
Description
Change in cardiac baroreflex sensitivity (change in heartbeat interval per mmHg blood pressure change) during blood pressure changes evoked by the Valsalva maneuver
Time Frame
Baseline to 90 days post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Green
Phone
949.231.7602
Email
lgreen@vasculardynamics.com
Facility Information:
Facility Name
Universitätsmedizin Mannheim
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Withdrawn
Facility Name
CVC Frankfurt
City
Frankfurt am Main
State/Province
Hesse
ZIP/Postal Code
60389
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine de Bruijn
Phone
+49 69 97947653
Email
s.debruijn@cvcfrankfurt.de
First Name & Middle Initial & Last Name & Degree
Horst Sievert, MD
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Lower Saxony
ZIP/Postal Code
30451
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Uniklinik Köln
City
Cologne
State/Province
North Rhine-Westphalia
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Completed
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
State/Province
North Rhine-Westphalia
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Completed
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Charite Berlin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Asklepiod Klinik Hamburg
City
Hamburg
Country
Germany
Individual Site Status
Completed
Facility Name
Universitatsklinikum des Saarlandes
City
Homburg
Country
Germany
Individual Site Status
Completed
Facility Name
HagaZiekenhuis
City
The Hague
State/Province
AA
ZIP/Postal Code
2545
Country
Netherlands
Individual Site Status
Completed
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
State/Province
EM
ZIP/Postal Code
3435
Country
Netherlands
Individual Site Status
Completed
Facility Name
Maastricht UMC+
City
Maastricht
State/Province
HX
ZIP/Postal Code
6229
Country
Netherlands
Individual Site Status
Completed
Facility Name
Radboud University Medical Center
City
Nijmegen
ZIP/Postal Code
6525GA
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid Klaassen
Phone
+31 88 7559954
Email
i.klaassen@umcutrecht.nl
First Name & Middle Initial & Last Name & Degree
Corina Joosten
Phone
+31 88 7559954
Email
C.A.M.Joosten@umcutrecht.nl
First Name & Middle Initial & Last Name & Degree
Wilko Spiering, MD, PhD
Facility Name
Isala
City
Zwolle
ZIP/Postal Code
8025AB
Country
Netherlands
Individual Site Status
Completed
Facility Name
Queen Elizabeth University Hospital - Glasgo
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Golden Jubilee National Hospital
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G81 4DY
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
The Royal Sussex County Hospital
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
St. Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Completed
Facility Name
St. Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
WC1E 6HX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna Moskal-Fitzpatrick
Phone
+44 207 679 9007
Ext
09007
Email
donna.moskal@ucl.ac.uk
First Name & Middle Initial & Last Name & Degree
Bryan Williams
First Name & Middle Initial & Last Name & Degree
Joe Brookes
Facility Name
Manchester University
City
Manchester
ZIP/Postal Code
M13 9PL
Country
United Kingdom
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34784359
Citation
van Kleef MEAM, Heusser K, Diedrich A, Oey PL, Tank J, Jordan J, Blankestijn PJ, Williams B, Spiering W. Endovascular baroreflex amplification and the effect on sympathetic nerve activity in patients with resistant hypertension: A proof-of-principle study. PLoS One. 2021 Nov 16;16(11):e0259826. doi: 10.1371/journal.pone.0259826. eCollection 2021.
Results Reference
derived

Learn more about this trial

Controlling and Lowering Blood Pressure With the MobiusHD™

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