Controlling And Lowering Blood Pressure With the MobiusHDTM Device

Not Applicable

Terminated

• Conditions: Hypertension
• Interventions: Device: MobiusHD; Other: Sham Implantation

• Registration Number: NCT02804087
• Lead Sponsor: Vascular Dynamics, Inc.

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-17
• Study Start: 2017-08-24
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-21
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MobiusHD Implantation	MobiusHD	-
Sham Implantation	Sham Implantation	Sham

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.	From Baseline to 30 days post-randomization	Adverse Events

Trial Locations

Locations (4)

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

HagaZiekenhuis; 🇳🇱 The Hague, AA, Netherlands

Maastricht UMC+; 🇳🇱 Maastricht, Netherlands

UMCU; 🇳🇱 Utrecht, Netherlands