Controlling and Lowering Blood Pressure With the MobiusHD™

Not Applicable

Recruiting

• Conditions: Hypertension
• Interventions: Device: MobiusHD™

• Registration Number: NCT02827032
• Lead Sponsor: Vascular Dynamics, Inc.

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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-06
• Study First Posted: 2016-07-11
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-06
• Primary Completion: 2024-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Evaluation of 24-hour systolic Ambulatory Blood Pressure Measurement (ABPM)	Baseline to ninety (90) days post treatment	Change in the mean 24-hours systolic Ambulatory Blood Pressure

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	Baseline to three (3) years post treatment	Incidence of SAEs and UADEs reported from implantation through three years post treatment

Trial Locations

Locations (22)

Universitatsklinikum des Saarlandes; 🇩🇪 Homburg, Germany

Universitätsklinikum Düsseldorf; 🇩🇪 Düsseldorf, North Rhine-Westphalia, Germany

Maastricht UMC+; 🇳🇱 Maastricht, HX, Netherlands

Universitätsmedizin Mannheim; 🇩🇪 Mannheim, Baden-Württemberg, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Lower Saxony, Germany

CVC Frankfurt; 🇩🇪 Frankfurt am Main, Hesse, Germany

Golden Jubilee National Hospital; 🇬🇧 Glasgow, Scotland, United Kingdom

Universitätsklinikum Schleswig-Holstein; 🇩🇪 Kiel, Schleswig-Holstein, Germany

Uniklinik Köln; 🇩🇪 Cologne, North Rhine-Westphalia, Germany

HagaZiekenhuis; 🇳🇱 The Hague, AA, Netherlands

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, EM, Netherlands

Universitair Medisch Centrum Utrecht; 🇳🇱 Utrecht, Netherlands

Isala; 🇳🇱 Zwolle, Netherlands

Radboud University Medical Center; 🇳🇱 Nijmegen, Netherlands

Queen Elizabeth University Hospital - Glasgo; 🇬🇧 Glasgow, Scotland, United Kingdom

St. Thomas' Hospital; 🇬🇧 London, United Kingdom

The Royal Sussex County Hospital; 🇬🇧 Brighton, United Kingdom

St. Bartholomew's Hospital; 🇬🇧 London, United Kingdom

University College London Hospital; 🇬🇧 London, United Kingdom

Manchester University; 🇬🇧 Manchester, United Kingdom

Asklepiod Klinik Hamburg; 🇩🇪 Hamburg, Germany

Charite Berlin; 🇩🇪 Berlin, Germany