RecruitingNot ApplicableNCT06310031

Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure

Investigation of a Novel, magNetically Levitated VAD for the Treatment of refractOry Left Ventricular heArT failurE

Sponsor

BrioHealth Solutions, Inc.

Enrollment

780 participants

Start Date

Oct 28, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Summary

The goal of this study is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3 Left Ventricular Assist System when used for the treatment of advanced, refractory, left ventricular heart failure.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new device called the BrioVAD — a left ventricular assist device (LVAD), which is a mechanical pump implanted in the chest to help a failing heart pump blood throughout the body. The study evaluates the device's safety and effectiveness in patients with severe, end-stage heart failure. **You may be eligible if...** - You are 18 years or older - You have severe heart failure (NYHA Class IV, meaning symptoms even at rest, or Class III with symptoms during mild activity) - Your heart's pumping function is severely reduced (ejection fraction 25% or lower) - You are dependent on intravenous heart medications or a temporary mechanical heart support device - A doctor has recommended you for an LVAD implant **You may NOT be eligible if...** - You have had a recent severe stroke or major bleeding event - You have a serious infection - You have other significant organ failure (liver, kidneys) - You are pregnant - You have aortic valve regurgitation that hasn't been repaired 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

DEVICEBrioVAD System

Implantation of the BrioVAD System to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3 LVAS when used for the treatment of advanced, refractory, left ventricular heart failure.

DEVICEHeartMate 3

Implantation of the commercially approved HeartMate 3 LVAS, which is the standard treatment for advanced heart failure.

Locations(37)

Baptist Health Medical Center-Little Rock

Little Rock, Arkansas, United States

UF Health Shands Hospital

Gainsville, Florida, United States

Advent Health

Orlando, Florida, United States

Piedmont Healthcare

Atlanta, Georgia, United States

Emory University

Atlanta, Georgia, United States

Advocate Christ Medical Center

Chicago, Illinois, United States

Northwestern University

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Ascension St. Vincent Hospital - Indianapolis

Indianapolis, Indiana, United States

University of Louisville

Louisville, Kentucky, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Health

Detriot, Michigan, United States

Corewell Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

University of Minnesota

Minneapolis, Minnesota, United States

WashU Medicine

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Newark Beth Israel Medical Center

Newark, New Jersey, United States

NYU Langone Health

New York, New York, United States

Mount Sinai

New York, New York, United States

Columbia University Irving Medical Center/ New York Presbyterian Hospital

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Duke University

Durham, North Carolina, United States

The Christ Hospital - Cincinnati

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Baptist - Memphis (Stern)

Memphis, Tennessee, United States

Baylor University Medical Center, part of Baylor Scott & White Health

Dallas, Texas, United States

UT southwestern Medical Center

Dallas, Texas, United States

Memorial Hermann-Texas Medical Center

Houston, Texas, United States

Baylor Scott & White Medical Center - Plano

Plano, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Inova Fairfax Medical Campus

Falls Church, Virginia, United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT06310031

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