RecruitingNot ApplicableNCT04590001

Effect of the MobiusHD® in Patients With Heart Failure

A Feasibility Study Exploring the Effect of the MobiusHD® in Patients With Heart Failure


Sponsor

Vascular Dynamics, Inc.

Enrollment

50 participants

Start Date

Oct 2, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, multi-center, open-label clinical trial intended to evaluate the safety and effectiveness of the MobiusHD® in patients with heart failure and reduced ejection fraction.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a small implantable device called MobiusHD, which is placed in the carotid artery in your neck. It works by activating natural pressure sensors (baroreceptors) to help lower blood pressure and reduce strain on the heart in people with heart failure. **You may be eligible if...** - You are 18 or older - You have heart failure with reduced pumping function (ejection fraction of 40% or less) - You are classified as NYHA Class II, III, or ambulatory Class IV heart failure (symptoms with mild to moderate activity) - Your heart failure has been stable on standard medications for at least 4 weeks - You can walk a moderate distance in 6 minutes (between 150 and 400 meters) **You may NOT be eligible if...** - You have had a prior stroke with permanent disability, brain bleeding, or serious brain injury - Your kidneys are significantly impaired - You have severe blockages in your carotid arteries - Your BMI is over 45 - You have had a cardiac resynchronization device placed in the last 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMobiusHD

The MobiusHD device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach.


Locations(17)

St. Vincent's Hospital

Darlinghurst, Sydney, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

London Health Science Center

London, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Helsicore Ltd "Israeli-Georgian Medical Research Clinic Helsicore"

Tbilisi, Georgia

Tbilisi Heart and Vascular Center

Tbilisi, Georgia

Charité Universitätsmedizin Berlin

Berlin, Germany

Heart Center, University Hospital Dresden

Dresden, Germany

CardioVascular Center - CVC Frankfurt

Frankfurt, Germany

Justus-Liebig-Universitat Giessen

Giessen, Germany

University of Saarlandes - Homburg

Homburg, Germany

Krankenhaus der Barmherzigen Brüder Trier

Trier, Germany

University Hospital Ulm

Ulm, Germany

Clinical Hospital Center Bežanijska Kosa, Belgrade

Belgrade, Serbia

Institut for Cardiovascular Disease Dedinje, Belgrade

Belgrade, Serbia

Institute for Cardiovascular Disease of Vojvodina

Kamenitz, Serbia

University Clinical Center, Kragujevac

Kragujevac, Serbia

View Full Details on ClinicalTrials.gov

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NCT04590001


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