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Cardiovascular DiseasesINNOVATENCT06310031

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

A study testing BrioVAD System and HeartMate 3 in people with Cardiovascular Diseases and Heart Diseases, run by BrioHealth Solutions, Inc. at 47 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
BrioVAD System and HeartMate 3
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
780 participants
Where
47 sitesUnited States
Study dates
28 Oct 2024to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

47 sites in 1 country.

47 sites in 1 country

United States47 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Piedmont Healthcare

    Atlanta, Georgia, 30309

  • Emory University

    Atlanta, Georgia, 30322

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • University of Alabama at Birmingham Hospital

    Birmingham, Alabama, 35233

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Advocate Christ Medical Center

    Chicago, Illinois, 60453

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60637

  • The Christ Hospital - Cincinnati

    Cincinnati, Ohio, 45219

  • Cleveland Clinic

    Cleveland, Ohio, 44195

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

    Dallas, Texas, 75246

  • UT southwestern Medical Center

    Dallas, Texas, 75390

  • Henry Ford Health

    Detriot, Michigan, 48202

  • Duke University

    Durham, North Carolina, 27710

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042

  • UF Health Shands Hospital

    Gainsville, Florida, 32608

  • Corewell Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Memorial Hermann-Texas Medical Center

    Houston, Texas, 77030

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

    Houston, Texas, 77030

  • Ascension St. Vincent Hospital - Indianapolis

    Indianapolis, Indiana, 46260

  • The University Of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Baptist Health Medical Center-Little Rock

    Little Rock, Arkansas, 72205

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • University of Louisville

    Louisville, Kentucky, 40202

  • Baptist - Memphis (Stern)

    Memphis, Tennessee, 38120

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • NYU Langone Health

    New York, New York, 10016

  • Mount Sinai

    New York, New York, 10029

  • Columbia University Irving Medical Center/ New York Presbyterian Hospital

    New York, New York, 10032

  • Weill Cornell Medicine

    New York, New York, 10065

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Advent Health

    Orlando, Florida, 32803

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Baylor Scott & White Medical Center - Plano

    Plano, Texas, 75093

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • University of Utah

    Salt Lake City, Utah, 84132

  • WashU Medicine

    St Louis, Missouri, 63110

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

About this study

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

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.

Read the detailed description

The INNOVATE Trial is a prospective, non-blinded, randomized, controlled, multi-center, non-inferiority study to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3™ (HM3) LVAS (Abbott) when used for the treatment of advanced, refractory left ventricular heart failure. It is the first clinical study to compare two left ventricular assist devices (LVAD) that belong to the same category of fully magnetically levitated LVAD.

Being tested
BrioVAD System, HeartMate 3
Keywords
Heart Failure, Left Ventricular Assist Device, Ventricular Dysfunction, Heart Disease, Cardiovascular Disease, Heart-assist Devices, Left Ventricular Assist System, BrioHealth Solutions
Medical subject headings
Cardiovascular Diseases, Heart Diseases, Heart Failure, Ventricular Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrioVAD SystemDevice

    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.

  • HeartMate 3Device

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

Study groups in NCT06310031
Study groupRoleWhat they receive
BrioVAD SystemExperimentalBrioVAD® Left Ventricular Assist System (BrioVAD® System) by BrioHealth Solutions, Inc.
Receives: Device: BrioVAD System
HeartMate 3Active comparatorHeartMate 3 System by Abbott
Receives: Device: HeartMate 3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months

  2. 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.

    Measured: 24 months

Secondary outcomes (3)

  1. Powered Secondary Endpoint

    Total number of nights in hospital, skilled nursing facility, or inpatient rehabilitation, inclusive of index hospitalization, through 24 months post VAD implant, heart transplantation, VAD explant or decommission, study withdrawal, or death, whichever occurs first.

    Measured: 24 months

  2. Short-Term Indication Secondary Endpoint

    Evaluation of the short-term safety using INTERMACS adverse event (AE) terms and definitions through 6 months post VAD implant, heart transplantation, VAD explant or decommission, study withdrawal, or death, whichever occurs first. Incidences of all AEs and the event rate per patient year of support through 6 months will be reported. Differences in the event rates between the Study Arm and the Concurrent Control Arm will be analyzed. Serious adverse events (SAEs) will be analyzed in a similar manner.

    Measured: 6 months

  3. Long-Term Indication Secondary Endpoint

    Evaluation of the long-term safety using INTERMACS AE terms and definitions through 24 months post VAD implant, heart transplantation, VAD explant or decommission, study withdrawal, or death, whichever occurs first. Incidences of all AEs and the event rate per patient year of support through 24 months will be reported. Differences in the event rates between the Study Arm and the Concurrent Control Arm will be analyzed. SAEs will be analyzed in a similar manner

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2024
  2. Study start28 Oct 2024
  3. Primary completionFeb 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
780 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06310031
Sponsor's protocol ID
CL-00545
Acronym
INNOVATE
Status last verified
Sep 2026
First submitted
7 Mar 2024
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided: Protocol and data is company confidential.

Questions about this trial

What is this clinical trial studying?

A study testing BrioVAD System and HeartMate 3 in people with Cardiovascular Diseases and Heart Diseases, run by BrioHealth Solutions, Inc. at 47 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short-Term Indication Primary Endpoint (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06310031.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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