Skip to content
Bored Studies
Recruiting

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

BrioHealth Solutions, Inc. · NCT06310031

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–100 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
780
US sites recruiting
47
Study start
October 28, 2024
Record last updated
September 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: BrioVAD System; HeartMate 3

Conditions: Cardiovascular Diseases; Heart Diseases; Heart Failure

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Patient is ≥ 18 years of age.
  • Patient has received institutional approval for LVAD implantation.
  • Patient has a body surface area (BSA) ≥ 1.2 m2.
  • Patient is classified as NYHA Class IV with advanced heart failure refractory to advanced heart failure management or NYHA Class III with dyspnea upon mild physical activity.
  • Patient has a left ventricular ejection fraction (LVEF) ≤ 25% or LVEF \< 30% on inotropes or temporary MCS.
  • Patient is inotrope dependent, OR has a cardiac index (CI) ≤ 2.2 liters/min/m2, while not on inotropes, and also meets one of the following criteria:
  • Is on optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and is failing to respond or is not able to tolerate OMM; or
  • Has advanced heart failure for at least 14 days and is dependent on an intra-aortic balloon pump (IABP) or temporary mechanical circulatory support device (MCSD) for at least seven days.
  • Patient has provided voluntary and informed consent.
  • Females of childbearing age agree to use adequate contraception and have a negative pregnancy test.

Exclusion Criteria

  • Patient's heart failure etiology is related to restrictive or constrictive physiology (e.g., nondilated hypertrophic cardiomyopathy, cardiac amyloidosis/senile or other infiltrative disease), complex congenital heart disease (e.g., transposition of the great vessels), uncorrected thyroid disease, and/or pericardial disease.
  • Patient had a myocardial infarction within seven days of study enrollment.
  • Patient had cardiothoracic surgery within 30 days of implant with the exception of a procedure to implant temporary MCS: Impella 5.5, Impella CP or TandemHeart.
  • Patient has physiological conditions or comorbidities which pose high surgical risk or obstacles as determined by the Investigator.
  • Patient has contraindications to warfarin anticoagulation.
  • Patient has known hypo- or hypercoagulable state [e.g., disseminated intravascular coagulation (DIC)], or has a positive heparin-induced thrombocytopenia (HIT) assay and positive serotonin release assay or requires use of a non-heparin alternative anticoagulation strategy for cardiopulmonary bypass in the judgement of the Investigator.
  • Patient is on durable MCS (e.g., LVAD or RVAD).
  • Planned need for durable or temporary RVAD support concomitant with LVAD implant.
  • Patient is on any form of pre-implant temporary MCS other than isolated LVAD support with an intra-aortic balloon pump, Impella 5.5, Impella CP, or TandemHeart.
  • Patient is on any form of pre-implant temporary MCS and has a serum lactate dehydrogenase greater than 2.5 times the upper limits of normal or plasma free hemoglobin > 40 g/dL.
  • Patient has a history of organ transplantation.
  • Patient has a mechanical aortic valve that may not be converted to a bioprosthetic valve at the time of VAD implant.
  • Patient has a platelet count \< 50 k/μl.
  • Patient has a history of confirmed untreated abdominal aortic aneurysm (AAA) > 5 cm in diameter.
  • Patient has moderate or severe aortic insufficiency that will not be corrected during the VAD implant procedure.
  • Patient has an uncontrolled systemic infection.
  • Patient has a positive COVID 19 test within 21 days of study enrollment and at least one high risk feature including need for supplemental oxygen or ferritin >1000 ug/L.
  • Patient has severe end-organ dysfunction as evidenced by one or more of the following criteria:
  • Total bilirubin > 3.0 mg/dL or cirrhosis confirmed by liver imaging or hemodynamic assessment with or without biopsy confirmation.
  • International normalized ratio (INR) ≥ 2.0 or PTT > 2.5 times control that is not related to anticoagulation therapy.
  • Glomerular filtration rate (GFR) \< 30 mL/ min/1.73 m2 or need for renal replacement therapy.
  • Severe pulmonary arterial hypertension with a pulmonary vascular resistance (PVR) ≥ 8 Wood units that is not acutely reversible with pharmacologic intervention.
  • Severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease requiring home oxygen or an FEV1/FVC \< 0.7 and FEV1 \< 40% predicted.
  • Mechanical ventilation for more than three days present at the time of study enrollment.
  • Documented history of pulmonary embolism or pulmonary infarct within 60 days of study enrollment.
  • History of stroke within 90 days of study enrollment or history of stroke with a mRS ≥ 3 at the time of study enrollment.
  • Symptomatic cerebrovascular disease and/or uncorrected carotid stenosis > 80%.
  • Significant peripheral vascular disease (PVD) accompanied by pain at rest or extremity ulceration.
  • Pre-albumin \< 15 mg/dL and/or albumin \< 2.5 g/dL.
  • Patient has a non-cardiac comorbidity or illness that would limit survival to less than two years.
  • Patient has a psychiatric disease or disorder, or irreversible cognitive dysfunction, and/or insufficient social support or a history of non-adherence with medical instructions that is likely to impair study compliance.
  • Patient is participating in an interventional clinical trial that may impact or confound the results of the INNOVATE Trial.

Recruiting US locations

  • University of Alabama at Birmingham Hospital

    Birmingham, AL 35233

    Site contact: Suzanne · (205) 934-3411 · suzannehwhite@uabmc.edu

  • Baptist Health Medical Center-Little Rock

    Little Rock, AR 72205

    Site contact: Leah Dawson · leah.dawson@baptist-health.org

  • Cedars-Sinai Medical Center

    Los Angeles, CA 90048

    Site contact: Mel CRC · (310) 423-3277 · Mel.Runyan@cshs.org

  • UF Health Shands Hospital

    Gainsville, FL 32608

    Site contact: Jessica Cobb · (352) 265-0111 · Jessica.Cobb@surgery.ufl.edu

  • Advent Health

    Orlando, FL 32803

    Site contact: Andrija Vidic, MD · (407) 303-5600 · andrija.vidic.do@adventhealth.com

  • Piedmont Healthcare

    Atlanta, GA 30309

    Site contact: Caryn Bernstein · 404-605-5151 · Caryn.Bernstein@piedmont.org

  • Emory University

    Atlanta, GA 30322

    Site contact: Maialen Odriozola, RN · 404-727-8340 · maialen.odriozolarodriguez@emory.edu

  • Advocate Christ Medical Center

    Chicago, IL 60453

    Site contact: Jillian Lux · (708) 684-8000 · Jillian.Lux@aah.org

  • Northwestern University

    Chicago, IL 60611

    Site contact: Anna Huskin · (312) 503-8194 · Anna.Huskin@nm.org

  • University of Chicago

    Chicago, IL 60637

    Site contact: Kayla Moore · 773-702-8228 · kaymoore@bsd.uchicago.edu

  • Ascension St. Vincent Hospital - Indianapolis

    Indianapolis, IN 46260

    Site contact: Regina Margiotti · (317) 338-2345 · regina.margiotti@ascension.org

  • The University Of Kansas Medical Center

    Kansas City, KS 66160

    Site contact: Kartik CRC · 913-588-5000 · kmunshi@kumc.edu

  • University of Kentucky

    Lexington, KY 40536

    Site contact: Jennifer CRC · 859-257-1000 · jennifer.isaacs@uky.edu

  • University of Louisville

    Louisville, KY 40202

    Site contact: Terry Blanton · 502-588-7600 · mary.blanton@louisville.edu

  • University of Maryland Medical Center

    Baltimore, MD 21201

    Site contact: Kaitlyn Masih · KMasih@som.umaryland.edu

  • The Johns Hopkins Hospital

    Baltimore, MD 21287

    Site contact: Lisa CRC · (410) 955-5000 · lisa.fornaresio@jhmi.edu

  • Tufts Medical Center

    Boston, MA 02111

    Site contact: Gaurav Das · (617) 636-5000 · Gaurav.Das@tuftsmedicine.org

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Tracy Winship · (617) 726-2000 · twinship@mgb.org

  • University of Michigan

    Ann Arbor, MI 48109

    Site contact: China Clinical Research Coordinator · chjgreen@med.umich.edu

  • Henry Ford Health

    Detriot, MI 48202

    Site contact: Samantha McCormack · 313-900-5613 · Smccorm7@hfhs.org

  • Corewell Health Grand Rapids Hospital

    Grand Rapids, MI 49503

    Site contact: Tracy Wiles · (616) 391-1774 · tracy.wiles@corewellhealth.org

  • Abbott Northwestern Hospital

    Minneapolis, MN 55407

    Site contact: Kate Jappe · 612-863-5855 · kate.jappe@allina.com

  • University of Minnesota

    Minneapolis, MN 55455

    Site contact: Jessica Schultz · 612-273-8383 · schu3455@umn.edu

  • WashU Medicine

    St Louis, MO 63110

    Site contact: Kyle Stumbaugh · 314-362-7260 · kyles@wustl.edu

  • University of Nebraska Medical Center

    Omaha, NE 68198

    Site contact: Jill Falkiewicz · 402-559-4000 · jill.falkiewicz@unmc.edu

  • Newark Beth Israel Medical Center

    Newark, NJ 07112

    Site contact: Sevani Robinson · (973) 926-7000 · Sevani.Robinson@rwjbh.org

  • NYU Langone Health

    New York, NY 10016

    Site contact: Nicolas Dundas · 646-929-7870 · Nicolas.Dundas@nyulangone.org

  • Mount Sinai

    New York, NY 10029

    Site contact: Caroline Tavolacci, MD · 800-637-4624 · Sooyun.Tavolacci@mountsinai.org

  • Columbia University Irving Medical Center/ New York Presbyterian Hospital

    New York, NY 10032

    Site contact: Bo Lu · bl2699@cumc.columbia.edu

  • Weill Cornell Medicine

    New York, NY 10065

    Site contact: Marshagay CRC · (212) 746-6565 · mar4028@med.cornell.edu

  • Montefiore Medical Center

    The Bronx, NY 10467

    Site contact: Magdalena Mamczur-Madry · 718-920-2626 · mmamczur@montefiore.org

  • Duke University

    Durham, NC 27710

    Site contact: Sarah Casalinova · (919) 613-5621 · sarah.casalinova@duke.edu

  • The Christ Hospital - Cincinnati

    Cincinnati, OH 45219

    Site contact: Michael Weber · 513-585-0038 · Michael.Weber@TheChristHospital.com

  • Cleveland Clinic

    Cleveland, OH 44195

    Site contact: Barb Gus, RN · 216-296-2799 · GUSB@ccf.org

  • Oregon Health & Science University

    Portland, OR 97239

    Site contact: Amy · 503-494-8311 · koskia@ohsu.edu

  • Thomas Jefferson University Hospital

    Philadelphia, PA 19107

    Site contact: Keshava PI · (215) 955-6000 · Keshava.Rajagopal@jefferson.edu

  • Medical University of South Carolina

    Charleston, SC 29425

    Site contact: Morgan Overstreet · (843) 792-5252 · overstrm@musc.edu

  • Baptist - Memphis (Stern)

    Memphis, TN 38120

    Site contact: Kari Fondren · (901) 271-1000 · kari.fondren@sterncardio.com

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

    Dallas, TX 75246

    Site contact: Aayla Jamil · (214) 820-0111 · Aayla.Jamil@BSWHealth.org

  • UT southwestern Medical Center

    Dallas, TX 75390

    Site contact: Sarah McNeil · 214-645-7700 · Sarah.McNeil@UTSouthwestern.edu

  • Houston Methodist Hospital

    Houston, TX 77030

    Site contact: Saba CRC · (713) 790-3311 · skhan5@houstonmethodist.org

  • Memorial Hermann-Texas Medical Center

    Houston, TX 77030

    Site contact: Lawana Self · Lawana.Self@uth.tmc.edu

  • Texas Heart Institute at Baylor St. Luke's Medical Center

    Houston, TX 77030

    Site contact: Jennifer CRC · 832-355-4011 · jchambers@texasheart.org

  • Baylor Scott & White Medical Center - Plano

    Plano, TX 75093

    Site contact: Osniel Gonzalez · (469) 814-2000 · osniel.gonzalezramos@bswhealth.org

  • University of Utah

    Salt Lake City, UT 84132

    Site contact: Ashley Study Coordinator · ashley.elmer@hsc.utah.edu

  • Inova Fairfax Medical Campus

    Falls Church, VA 22042

    Site contact: Bhruga Shah · (703) 776-4001 · Bhruga.Shah@inova.org

  • Aurora St. Luke's Medical Center

    Milwaukee, WI 53215

    Site contact: Donald Lobacz · Donald.Lobacz@aah.org

Study contacts (from the official record)

  • Pranesh Thirukkonda · 12014016539 · pranesh.thirukkonda@briohealth.com
  • Lynda McMahon · 15085252203 · lynda.mcmahon@briohealth.com
All heart & blood pressure studies in Alabama →
Investigation of the BrioVAD System for the Treatment of Left… (NCT06310031) | Bored Studies