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Device

MobiusHD Device for High Blood Pressure (CALM-2 Trial)

N/A
Waitlist Available
Research Sponsored by Vascular Dynamics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180-day

Summary

This trial is testing a new heart device to see if it is safe and effective. The study will compare the new device to a fake (sham) device.

Who is the study for?
This trial is for adults with high blood pressure that's stayed high (145-200 mmHg) despite taking up to 5 different blood pressure meds, including a specific combo of an ACE inhibitor or angiotensin receptor blocker, calcium channel blocker, and diuretic. People can't join if their carotid artery anatomy isn't right for the MobiusHD device based on special X-ray tests.
What is being tested?
The CALM-2 study is testing how safe and effective the MobiusHD System is at lowering blood pressure compared to a fake procedure. Participants won't know which one they get in this controlled study where treatments are assigned randomly.
What are the potential side effects?
While not specified here, potential side effects may include discomfort or complications from implantation procedures, reactions to the device itself once placed inside the body, and any impacts it might have on blood flow or heart function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180-day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 180-day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Effectiveness Endpoint - Change in mean 24-hr sABP from baseline to 180-day
Other study objectives
Safety Assessments - Composite measured at 90-day

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MobiusHD ImplantationExperimental Treatment1 Intervention
MobiusHD Implantation
Group II: Sham ImplantationPlacebo Group1 Intervention
Sham Implantation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MobiusHD
2013
N/A
~30

Find a Location

Who is running the clinical trial?

Vascular Dynamics, Inc.Lead Sponsor
6 Previous Clinical Trials
301 Total Patients Enrolled
Bryan Williams, MDStudy ChairUniversity College, London
Gregg Stone, MDStudy ChairCardiovascular Research and Education Columbia University Medical Center
13 Previous Clinical Trials
5,099 Total Patients Enrolled

Media Library

MobiusHD (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03179800 — N/A
High Blood Pressure (Hypertension) Research Study Groups: MobiusHD Implantation, Sham Implantation
High Blood Pressure (Hypertension) Clinical Trial 2023: MobiusHD Highlights & Side Effects. Trial Name: NCT03179800 — N/A
MobiusHD (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03179800 — N/A
~13 spots leftby May 2025
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