Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure (INNOVATE)

March 27, 2026 updated by: BrioHealth Solutions, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

780

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • Florida
      • Gainsville, Florida, United States, 32608
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Advent Health
        • Principal Investigator:
          • Andrija Vidic, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Healthcare
        • Contact:
        • Principal Investigator:
          • Ezequiel Molina, MD
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
      • Chicago, Illinois, United States, 60453
        • Recruiting
        • Advocate Christ Medical Center
        • Principal Investigator:
          • Antone Tatooles, MD
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Ascension St. Vincent Hospital - Indianapolis
        • Principal Investigator:
          • Ashwin Ravichandran, MD
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville
        • Contact:
        • Principal Investigator:
          • Mark Slaughter
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland Medical Center
        • Contact:
        • Principal Investigator:
          • Howard Massey
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • David D'Alessandro, MD
        • Contact:
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Tufts Medical Center
        • Contact:
        • Principal Investigator:
          • Gaurav Gulati
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
      • Detriot, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health
        • Contact:
      • Grand Rapids, Michigan, United States, 49503
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
        • Principal Investigator:
          • Andrew Shaffer
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott Northwestern Hospital
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • WashU Medicine
        • Contact:
        • Principal Investigator:
          • Amit Pawale
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Scott Lundgren
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Recruiting
        • Newark Beth Israel Medical Center
        • Contact:
        • Principal Investigator:
          • Igor Gosev, MD
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Contact:
        • Principal Investigator:
          • Marzia Leacche, MD
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai
        • Contact:
        • Principal Investigator:
          • Anelechi Anyanwu
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center/ New York Presbyterian hospital
        • Contact:
        • Principal Investigator:
          • Koji Takeda
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Principal Investigator:
          • Daniel Goldstein, MD
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
          • Barb Gus, RN
          • Phone Number: 216-296-2799
          • Email: GUSB@ccf.org
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Arman Kilic
        • Contact:
    • Tennessee
      • Memphis, Tennessee, United States, 38120
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center
        • Contact:
        • Principal Investigator:
          • Matthias Peltz
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor University Medical Center, part of Baylor Scott & White Health
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Memorial Hermann-Texas Medical Center
        • Contact:
        • Principal Investigator:
          • Igor Gregoric
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Scott & White Medical Center - Plano
        • Contact:
        • Principal Investigator:
          • David Rawitscher
    • Utah
      • Salt Lake City, Utah, United States, 84132
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Inova Fairfax Medical Campus
        • Principal Investigator:
          • Palak Shah, MD
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora St. Luke's Medical Center
        • Contact:
        • Principal Investigator:
          • Sulemanjee Nasir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient is ≥ 18 years of age.
  2. Patient has received institutional approval for LVAD implantation.
  3. Patient has a body surface area (BSA) ≥ 1.2 m2.
  4. 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.
  5. Patient has a left ventricular ejection fraction (LVEF) ≤ 25% or LVEF < 30% on inotropes or temporary MCS.

  6. 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:

    1. 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
    2. 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.
  7. Patient has provided voluntary and informed consent.
  8. Females of childbearing age agree to use adequate contraception and have a negative pregnancy test.

Exclusion Criteria:

  1. 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.
  2. Patient had a myocardial infarction within seven days of study enrollment.
  3. 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.
  4. Patient has physiological conditions or comorbidities which pose high surgical risk or obstacles as determined by the Investigator.
  5. Patient has contraindications to warfarin anticoagulation.
  6. 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.
  7. Patient is on durable MCS (e.g., LVAD or RVAD).
  8. Planned need for durable or temporary RVAD support concomitant with LVAD implant.
  9. 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.
  10. 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.
  11. Patient has a history of organ transplantation.
  12. Patient has a mechanical aortic valve that may not be converted to a bioprosthetic valve at the time of VAD implant.
  13. Patient has a platelet count < 50 k/μl.
  14. Patient has a history of confirmed untreated abdominal aortic aneurysm (AAA) > 5 cm in diameter.
  15. Patient has moderate or severe aortic insufficiency that will not be corrected during the VAD implant procedure.
  16. Patient has an uncontrolled systemic infection.
  17. 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.

  18. Patient has severe end-organ dysfunction as evidenced by one or more of the following criteria:

    1. Total bilirubin > 3.0 mg/dL or cirrhosis confirmed by liver imaging or hemodynamic assessment with or without biopsy confirmation.
    2. International normalized ratio (INR) ≥ 2.0 or PTT > 2.5 times control that is not related to anticoagulation therapy.
    3. Glomerular filtration rate (GFR) < 30 mL/ min/1.73 m2 or need for renal replacement therapy.
    4. Severe pulmonary arterial hypertension with a pulmonary vascular resistance (PVR) ≥ 8 Wood units that is not acutely reversible with pharmacologic intervention.
    5. Severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease requiring home oxygen or an FEV1/FVC < 0.7 and FEV1 < 40% predicted.
    6. Mechanical ventilation for more than three days present at the time of study enrollment.
    7. Documented history of pulmonary embolism or pulmonary infarct within 60 days of study enrollment.
    8. History of stroke within 90 days of study enrollment or history of stroke with a mRS ≥ 3 at the time of study enrollment.
    9. Symptomatic cerebrovascular disease and/or uncorrected carotid stenosis > 80%.
    10. Significant peripheral vascular disease (PVD) accompanied by pain at rest or extremity ulceration.
    11. Pre-albumin < 15 mg/dL and/or albumin < 2.5 g/dL.
  19. Patient has a non-cardiac comorbidity or illness that would limit survival to less than two years.
  20. 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.
  21. Patient is participating in an interventional clinical trial that may impact or confound the results of the INNOVATE Trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BrioVAD System
BrioVAD® Left Ventricular Assist System (BrioVAD® System) by BrioHealth Solutions, Inc.
Device: BrioVAD 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.
Active Comparator: HeartMate 3
HeartMate 3 System by Abbott
Device: HeartMate 3
Implantation of the commercially approved HeartMate 3 LVAS, which is the standard treatment for advanced heart failure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-Term Indication Primary Endpoint
Time Frame: 6 months
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
Time Frame: 24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Powered Secondary Endpoint
Time Frame: 24 months
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.
24 months
Short-Term Indication Secondary Endpoint
Time Frame: 6 months
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.
6 months
Long-Term Indication Secondary Endpoint
Time Frame: 24 months
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BrioHealth Solutions, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2024

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-00545

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Protocol and data is company confidential.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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