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

NCT06310031

This study is recruiting at 45 US sites in 27 states, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Cardiovascular Diseases
  • Heart Diseases
  • Heart Failure

Eligibility basics and study details

Study type
Interventional
Phase
Not applicable
Ages
18 to 100 years
Sex
All
Healthy volunteers
Not accepted
Sponsor
BrioHealth Solutions, Inc.
Last updated on ClinicalTrials.gov
September 9, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Alabama · 1

  • University of Alabama at Birmingham Hospital · Birmingham, AL

Arkansas · 1

  • Baptist Health Medical Center-Little Rock · Little Rock, AR

California · 1

  • Cedars-Sinai Medical Center · Los Angeles, CA

Florida · 1

  • Advent Health · Orlando, FL

Georgia · 2

  • Emory University · Atlanta, GA
  • Piedmont Healthcare · Atlanta, GA

Illinois · 3

  • Advocate Christ Medical Center · Chicago, IL
  • Northwestern University · Chicago, IL
  • University of Chicago · Chicago, IL

Indiana · 1

  • Ascension St. Vincent Hospital - Indianapolis · Indianapolis, IN

Kansas · 1

  • The University Of Kansas Medical Center · Kansas City, KS

Kentucky · 2

  • University of Kentucky · Lexington, KY
  • University of Louisville · Louisville, KY

Maryland · 2

  • The Johns Hopkins Hospital · Baltimore, MD
  • University of Maryland Medical Center · Baltimore, MD

Massachusetts · 2

  • Massachusetts General Hospital · Boston, MA
  • Tufts Medical Center · Boston, MA

Michigan · 2

  • University of Michigan · Ann Arbor, MI
  • Corewell Health Grand Rapids Hospital · Grand Rapids, MI

Minnesota · 2

  • Abbott Northwestern Hospital · Minneapolis, MN
  • University of Minnesota · Minneapolis, MN

Missouri · 1

  • WashU Medicine · St Louis, MO

Nebraska · 1

  • University of Nebraska Medical Center · Omaha, NE

New Jersey · 1

  • Newark Beth Israel Medical Center · Newark, NJ

New York · 5

  • Columbia University Irving Medical Center/ New York Presbyterian Hospital · New York, NY
  • Mount Sinai · New York, NY
  • NYU Langone Health · New York, NY
  • Weill Cornell Medicine · New York, NY
  • Montefiore Medical Center · The Bronx, NY

North Carolina · 1

  • Duke University · Durham, NC

Ohio · 2

  • The Christ Hospital - Cincinnati · Cincinnati, OH
  • Cleveland Clinic · Cleveland, OH

Oregon · 1

  • Oregon Health & Science University · Portland, OR

Pennsylvania · 1

  • Thomas Jefferson University Hospital · Philadelphia, PA

South Carolina · 1

  • Medical University of South Carolina · Charleston, SC

Tennessee · 1

  • Baptist - Memphis (Stern) · Memphis, TN

Texas · 6

  • Baylor University Medical Center, part of Baylor Scott & White Health · Dallas, TX
  • UT southwestern Medical Center · Dallas, TX
  • Houston Methodist Hospital · Houston, TX
  • Memorial Hermann-Texas Medical Center · Houston, TX
  • Texas Heart Institute at Baylor St. Luke's Medical Center · Houston, TX
  • Baylor Scott & White Medical Center - Plano · Plano, TX

Utah · 1

  • University of Utah · Salt Lake City, UT

Virginia · 1

  • Inova Fairfax Medical Campus · Falls Church, VA

Wisconsin · 1

  • Aurora St. Luke's Medical Center · Milwaukee, WI

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.