Actively Recruiting
Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure
Led by BrioHealth Solutions, Inc. · Updated on 2026-04-01
780
Participants Needed
37
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years of age or older.
- Patient has approval for left ventricular assist device (LVAD) implantation.
- Patient has a body surface area of 1.2 m2 or more.
- Patient is classified as NYHA Class IV with advanced heart failure not responding to treatment or NYHA Class III with shortness of breath on mild activity.
- Patient has a left ventricular ejection fraction of 25% or less, or less than 30% if on inotropes or temporary mechanical support.
- Patient is inotrope dependent or has a cardiac index of 2.2 liters/min/m2 or less while off inotropes, and either has been on optimal medical management for at least 45 of the last 60 days without improvement, or has advanced heart failure for at least 14 days and depends on an intra-aortic balloon pump or temporary mechanical support for at least seven days.
- Patient has given voluntary informed consent.
- Females of childbearing potential agree to use effective contraception and have a negative pregnancy test.
You will not qualify if you...
- Heart failure caused by restrictive or constrictive physiology, complex congenital heart disease, uncorrected thyroid disease, or pericardial disease.
- Myocardial infarction within seven days before enrollment.
- Cardiothoracic surgery within 30 days before implant, except implantation of temporary mechanical support devices like Impella or TandemHeart.
- Conditions or comorbidities posing high surgical risk.
- Contraindications to warfarin anticoagulation.
- Known clotting disorders or positive heparin-induced thrombocytopenia tests requiring special anticoagulation.
- Use of durable mechanical circulatory support devices.
- Planned need for right ventricular assist device along with LVAD implant.
- Use of certain temporary mechanical support devices with elevated markers of blood damage.
- History of organ transplantation.
- Presence of mechanical aortic valve that cannot be replaced.
- Low platelet count below 50,000 per microliter.
- Untreated abdominal aortic aneurysm larger than 5 cm.
- Moderate or severe aortic valve leakage not corrected during implant.
- Uncontrolled systemic infection.
- Positive COVID-19 test within 21 days plus high-risk features.
- Severe organ dysfunction including liver, kidney, lung, or blood clotting abnormalities.
- Severe lung disease requiring home oxygen or impaired lung function.
- Mechanical ventilation for more than three days at enrollment.
- Recent pulmonary embolism or stroke within specified time frames.
- Significant cerebrovascular or peripheral vascular disease.
- Low nutritional markers such as pre-albumin or albumin.
- Non-cardiac illnesses limiting survival to less than two years.
- Psychiatric or cognitive conditions or lack of social support likely to impair compliance.
- Participation in other interventional clinical trials that may affect results.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 37 locations
1
Baptist Health Medical Center-Little Rock
Little Rock, Arkansas, United States, 72205
Actively Recruiting
2
UF Health Shands Hospital
Gainsville, Florida, United States, 32608
Actively Recruiting
3
Advent Health
Orlando, Florida, United States, 32803
Actively Recruiting
4
Piedmont Healthcare
Atlanta, Georgia, United States, 30309
Actively Recruiting
5
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
6
Advocate Christ Medical Center
Chicago, Illinois, United States, 60453
Actively Recruiting
7
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
8
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
9
Ascension St. Vincent Hospital - Indianapolis
Indianapolis, Indiana, United States, 46260
Actively Recruiting
10
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
11
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
12
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
13
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
14
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
15
Henry Ford Health
Detriot, Michigan, United States, 48202
Actively Recruiting
16
Corewell Health Grand Rapids Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
17
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
18
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
19
WashU Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
20
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
21
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Actively Recruiting
22
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
23
Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
24
Columbia University Irving Medical Center/ New York Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
25
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
26
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
27
The Christ Hospital - Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
28
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
29
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
30
Baptist - Memphis (Stern)
Memphis, Tennessee, United States, 38120
Actively Recruiting
31
Baylor University Medical Center, part of Baylor Scott & White Health
Dallas, Texas, United States, 75246
Actively Recruiting
32
UT southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
33
Memorial Hermann-Texas Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
34
Baylor Scott & White Medical Center - Plano
Plano, Texas, United States, 75093
Actively Recruiting
35
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
36
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042
Actively Recruiting
37
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Actively Recruiting
Research Team
P
Pranesh Thirukkonda
CONTACT
L
Lynda McMahon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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