Controlling and Lowering Blood Pressure With the MobiusHD™

Hypertension Clinical Trial

— CALM-DIEM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02827032
• Other study ID #: CRD0328
• Status: Recruiting
• Phase: N/A
• Start date: July 2016
• Est. completion date: June 2026

Study information

• Verified date: October 2023
• Source: Vascular Dynamics, Inc.
• Contact: Lisa Green
• Phone: 949.231.7602
• Email: lgreen[@]vasculardynamics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
Germany	Charite Berlin	Berlin
Germany	Uniklinik Köln	Cologne	North Rhine-Westphalia
Germany	Universitätsklinikum Düsseldorf	Düsseldorf	North Rhine-Westphalia
Germany	CVC Frankfurt	Frankfurt am Main	Hesse
Germany	Asklepiod Klinik Hamburg	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover	Lower Saxony
Germany	Universitatsklinikum des Saarlandes	Homburg
Germany	Universitätsklinikum Schleswig-Holstein	Kiel	Schleswig-Holstein
Germany	Universitätsmedizin Mannheim	Mannheim	Baden-Württemberg
Netherlands	Maastricht UMC+	Maastricht	HX
Netherlands	St. Antonius Ziekenhuis	Nieuwegein	EM
Netherlands	Radboud University Medical Center	Nijmegen
Netherlands	HagaZiekenhuis	The Hague	AA
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Netherlands	Isala	Zwolle
United Kingdom	The Royal Sussex County Hospital	Brighton
United Kingdom	Golden Jubilee National Hospital	Glasgow	Scotland
United Kingdom	Queen Elizabeth University Hospital - Glasgo	Glasgow	Scotland
United Kingdom	St. Bartholomew's Hospital	London
United Kingdom	St. Thomas' Hospital	London
United Kingdom	University College London Hospital	London
United Kingdom	Manchester University	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Dynamics, Inc.

Countries where clinical trial is conducted

Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Substudy Outcome Measure - Change in sympathetic activity	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
Other	Substudy Outcome Measure - Change in sympathetic activity	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
Other	Substudy Outcome Measure - Change in sympathetic activity	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
Other	Substudy Outcome Measure - Change in baroreflex sensitivity	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
Other	Substudy Outcome Measure - Change in baroreflex sensitivity	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
Other	Substudy Outcome Measure - Change in baroreflex sensitivity	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
Other	Substudy Outcome Measure - Change in baroreflex sensitivity	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
Primary	Evaluation of 24-hour systolic Ambulatory Blood Pressure Measurement (ABPM)	Change in the mean 24-hours systolic Ambulatory Blood Pressure	Baseline to ninety (90) days post treatment
Secondary	Incidence of Adverse Events	Incidence of SAEs and UADEs reported from implantation through three years post treatment	Baseline to three (3) years post treatment