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

NCT06310031 | Recruiting DMC FDA Device

• 1 other identifier: CL-00545
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 37

Brief 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.

Conditions

Heart Diseases; Heart Failure; Cardiovascular Diseases

Keywords

Heart Failure; Left Ventricular Assist Device; Ventricular Dysfunction; Heart Disease; Cardiovascular Disease; Heart-assist Devices; Left Ventricular Assist System; BrioHealth Solutions

Outcome Measures

Primary Outcomes (2)

• Short-Term Indication Primary Endpoint

  Composite of survival to transplant, recovery or 6 months of LVAD support free of debilitating stroke \[modified Rankin Scale (mRS) \> 3\], or reoperation to replace the pump

  6 months

• Long-Term Indication Primary Endpoint

  Composite of survival to transplant, recovery or 24 months of LVAD support free of debilitating stroke (mRS \> 3), or reoperation to replace the pump.

  24 months

Secondary Outcomes (3)

• Powered Secondary Endpoint

  24 months

• Short-Term Indication Secondary Endpoint

  6 months

• Long-Term Indication Secondary Endpoint

  24 months

Study Arms (2)

BrioVAD System

EXPERIMENTAL

BrioVAD® Left Ventricular Assist System (BrioVAD® System) by BrioHealth Solutions, Inc.

Device: BrioVAD System

HeartMate 3

ACTIVE COMPARATOR

HeartMate 3 System by Abbott

Device: HeartMate 3

Interventions

BrioVAD System DEVICE

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.

BrioVAD System

HeartMate 3 DEVICE

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

HeartMate 3

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BrioHealth Solutions, Inc.: lead

Study Sites (37)

Baptist Health Medical Center-Little Rock

Little Rock, Arkansas, 72205, United States

RECRUITING

UF Health Shands Hospital

Gainsville, Florida, 32608, United States

RECRUITING

Advent Health

Orlando, Florida, 32803, United States

RECRUITING

Piedmont Healthcare

Atlanta, Georgia, 30309, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Advocate Christ Medical Center

Chicago, Illinois, 60453, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Ascension St. Vincent Hospital - Indianapolis

Indianapolis, Indiana, 46260, United States

RECRUITING

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Henry Ford Health

Detriot, Michigan, 48202, United States

RECRUITING

Corewell Health Grand Rapids Hospital

Grand Rapids, Michigan, 49503, United States

RECRUITING

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

WashU Medicine

St Louis, Missouri, 63110, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Mount Sinai

New York, New York, 10029, United States

RECRUITING

Columbia University Irving Medical Center/ New York Presbyterian Hospital

New York, New York, 10032, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

The Christ Hospital - Cincinnati

Cincinnati, Ohio, 45219, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Baptist - Memphis (Stern)

Memphis, Tennessee, 38120, United States

RECRUITING

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

Dallas, Texas, 75246, United States

RECRUITING

UT southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Memorial Hermann-Texas Medical Center

Houston, Texas, 77030, United States

RECRUITING

Baylor Scott & White Medical Center - Plano

Plano, Texas, 75093, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

RECRUITING

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Heart Failure; Ventricular Dysfunction

Central Study Contacts

Pranesh Thirukkonda

CONTACT

12014016539; pranesh.thirukkonda@briohealth.com

Lynda McMahon

CONTACT

15085252203; lynda.mcmahon@briohealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 13, 2024
• Study Start: October 28, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (37)