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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

Awards & highlights

CALM-2 Trial 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.Check my eligibility

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.See study design

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.

CALM-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 180-day

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Effectiveness Endpoint - Change in mean 24-hr sABP from baseline to 180-day

Other outcome measures

Safety Assessments - Composite measured at 90-day

CALM-2 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Vascular Dynamics, Inc.Lead Sponsor

6 Previous Clinical Trials

301 Total Patients Enrolled

Gregg Stone, MDStudy ChairCardiovascular Research and Education Columbia University Medical Center

13 Previous Clinical Trials

5,655 Total Patients Enrolled

Bryan Williams, MDStudy ChairUniversity College, London

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment currently open for this research project?

"This medical trial, which was initiated in October 2017, is not currently seeking applicants. As specified on clinicaltrials.gov, however, there are 745 other studies that do require the participation of patients."

Answered by AI

Is it possible to register for this trial?

"To be successful applicants in this experiment, potential participants must sustain hypertension and have an age between 18-80. This trial is seeking 300 candidates overall."

Answered by AI

Do you accept volunteers over the age of 55 for this research project?

"Per the study's eligibility requirements, only individuals aged between 18 and 80 can participate in this trial."

Answered by AI

How many study sites are participating in this research?

"Patients can register for this trial at Franciscan Health in Indianapolis, Indiana, St. Clair Nephrology Research in Roseville, Michigan, and Capital Area Research in Camp Hill, Pennsylvania as well as another 21 sites across the country."

Answered by AI