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New magnetic heart pump could offer hope for advanced heart failure patients

NCT ID NCT06310031

Disease control Sponsor: BrioHealth Solutions, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This study tests a new heart pump called BrioVAD for people with severe heart failure that doesn't get better with standard treatments. The pump uses magnetic levitation to help the heart pump blood. About 780 adults will get either the BrioVAD or an existing pump to see if the new one is as safe and effective. The goal is to help patients survive until a heart transplant or recover, while avoiding serious strokes or the need for another pump surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 780 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

advanced heart failure cardiovascular disorder heart disorder heart failure left ventricular failure Ventricular Dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases Heart diseases Heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    47 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Abbott Northwestern Hospital

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Advent Health

    RECRUITING

    Orlando, Florida, 32803, United States

  • Advocate Christ Medical Center

    RECRUITING

    Chicago, Illinois, 60453, United States

  • Ascension St. Vincent Hospital - Indianapolis

    RECRUITING

    Indianapolis, Indiana, 46260, United States

  • Aurora St. Luke's Medical Center

    RECRUITING

    Milwaukee, Wisconsin, 53215, United States

  • Baptist - Memphis (Stern)

    RECRUITING

    Memphis, Tennessee, 38120, United States

  • Baptist Health Medical Center-Little Rock

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • Baylor Scott & White Medical Center - Plano

    RECRUITING

    Plano, Texas, 75093, United States

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

    RECRUITING

    Dallas, Texas, 75246, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Columbia University Irving Medical Center/ New York Presbyterian Hospital

    RECRUITING

    New York, New York, 10032, United States

  • Corewell Health Grand Rapids Hospital

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Henry Ford Health

    RECRUITING

    Detriot, Michigan, 48202, United States

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Inova Fairfax Medical Campus

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Memorial Hermann-Texas Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Newark Beth Israel Medical Center

    RECRUITING

    Newark, New Jersey, 07112, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Piedmont Healthcare

    RECRUITING

    Atlanta, Georgia, 30309, United States

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

    RECRUITING

    Houston, Texas, 77030, United States

  • The Christ Hospital - Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • The Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • The University Of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Thomas Jefferson University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Tufts Medical Center

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • UF Health Shands Hospital

    RECRUITING

    Gainsville, Florida, 32608, United States

  • UT southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Alabama at Birmingham Hospital

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Louisville

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Maryland Medical Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • WashU Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medicine

    RECRUITING

    New York, New York, 10065, United States

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