Controlling And Lowering Blood Pressure With the MobiusHDTM Device

Vascular Dynamics, Inc.4 enrolled

Overview

To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.

This is a prospective, randomized, double-blind, sham-controlled, multi-center post market study investigating the efficacy and safety of MobiusHD System, and the efficacy of the MobiusHD device in lowering mean systolic 24-hour ABP in subjects with resistant hypertension.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hypertension

Interventions

MobiusHDDEVICE

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

Sham ImplantationOTHER

Sham Implantation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 18-70 years; * Diagnosed with resistant hypertension; * A mean systolic 24-hour ABP of 135-170 mmHg following at least 30 days on a stable antihypertensive medication regimen (no changes in medications or dose). * A mean systolic 24-hour ABP of 135-170 mmHg after washout of all antihypertensive medications. Exclusion Criteria: * Known or clinically suspected baroreflex failure or autonomic neuropathy * Treatable cause of resistant hypertension * Hypertension secondary to an identifiable and treatable cause other than sleep apnea

Locations (4)

HagaZiekenhuis

The Hague, AA, Netherlands

Maastricht UMC+

Maastricht, Netherlands

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

UMCU

Utrecht, Netherlands

Outcomes

Primary Outcomes

The change in mean systolic 24-hour ABP from baseline to 90 days post-randomization, between the treatment arm and the sham arm.

Reduction in mean systolic 24-hour ABP

Time frame: From Baseline to 90 days post-randomization

Secondary Outcomes

Major adverse clinical events, including death, stroke, carotid interventions, and myocardial infarction, from baseline to 30 days post-randomization, between the treatment arm and the sham arm.

Adverse Events

Time frame: From Baseline to 30 days post-randomization

Data from ClinicalTrials.gov

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