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Official title Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure
ClinicalTrials.gov ID: NCT06310031
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join 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...
- Patient has a left ventricular ejection fraction (LVEF) ≤ 25% or LVEF \< 30% on inotropes or temporary MCS.
You likely can't join if
- Patient's heart failure etiology is related to restrictive or constrictive physiology (e.g., nondilated hypertrophic cardiomyopathy, cardiac...
- 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...
- 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...
See the full eligibility criteria
Who can 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:
- 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.
What rules you out
- 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...
- 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...
- 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 treatment clinical trial that may impact or confound the results of the INNOVATE Trial.
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Gainsville, Florida, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detriot, Michigan, United States
- Grand Rapids, Michigan, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Newark, New Jersey, United States
- New York, New York, United States
- The Bronx, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
+ 9 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Gainsville, Florida, United States; Orlando, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Indianapolis, Indiana, United States and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.