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

Plain English Summary

Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure is a Not Applicable clinical trial sponsored by BrioHealth Solutions, Inc. studying Cardiovascular Diseases, Heart Diseases, Heart Failure. This trial tests a new magnetically levitated heart pump called the BrioVAD System. It is for adults with advanced heart failure that hasn't responded to other treatments. Participation involves receiving either the new BrioVAD or the current standard device (HeartMate 3) through surgery. The alternative is to continue with current medical management or other available treatments for advanced heart failure. The trial aims to enroll 780 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with advanced heart failure who are approved for a heart pump implant. Patients must have a weakened left ventricle (ejection fraction of 25% or less) and be dependent on medication or other support. Individuals with certain heart conditions like restrictive cardiomyopathy, recent heart attack, or uncontrolled infections cannot participate. Those with severe organ dysfunction or a life expectancy of less than two years due to other illnesses are also excluded. This trial is studying Cardiovascular Diseases, Heart Diseases, Heart Failure, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures will determine if the new BrioVAD system works as well as the current standard device in supporting the heart's function over time, meaning patients could benefit from a c The specific primary outcome measures are: Short-Term Indication Primary Endpoint (6 months); Long-Term Indication Primary Endpoint (24 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial is important because it aims to provide a potentially improved mechanical heart pump option for patients with severe heart failure, addressing a significant unmet need in treatment. This research targets Cardiovascular Diseases, Heart Diseases, Heart Failure, where improved treatment options are needed.

Investor Insight

This trial signals a competitive market for left ventricular assist devices (LVADs), with BrioHealth Solutions aiming to demonstrate their novel technology is at least as effective as the established The large enrollment target of 780 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about the risks and benefits of both the BrioVAD and HeartMate 3, and if you meet the specific criteria for this study. If you join, you will undergo surgery to implant the device and will require regular follow-up appointments and monitoring. Daily life may involve taking blood thinners and adhering to specific lifestyle recommendations to manage the device and your health. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 780 participants

Interventions

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

Primary Outcomes

• Short-Term Indication Primary Endpoint (6 months)
• Long-Term Indication Primary Endpoint (24 months)

Secondary Outcomes

• Powered Secondary Endpoint (24 months)
• Short-Term Indication Secondary Endpoint (6 months)
• Long-Term Indication Secondary Endpoint (24 months)

Full Eligibility Criteria

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 cognit

Trial Locations

• Baptist Health Medical Center-Little Rock, Little Rock, Arkansas, United States
• UF Health Shands Hospital, Gainsville, Florida, United States
• Advent Health, Orlando, Florida, United States
• Piedmont Healthcare, Atlanta, Georgia, United States
• Emory University, Atlanta, Georgia, United States
• Advocate Christ Medical Center, Chicago, Illinois, United States
• Northwestern University, Chicago, Illinois, United States
• University of Chicago, Chicago, Illinois, United States
• Ascension St. Vincent Hospital - Indianapolis, Indianapolis, Indiana, United States
• University of Louisville, Louisville, Kentucky, United States
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Heart Failure
• Cardiomyopathy
• Cardiovascular Diseases
• Congestive Heart Failure
• Left Ventricular Dysfunction
• End-Stage Heart Disease
• Heart Transplantation
• Mechanical Circulatory Support
• Arrhythmia
• Coronary Artery Disease

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