BrioVAD System for Heart Failure

(INNOVATE Trial)

Recruiting at 26 trial locations

Overseen By Lynda McMahon

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BrioHealth Solutions, Inc.

Must be taking: Inotropes

Must not be taking: Warfarin alternatives

Disqualifiers: Organ transplant, Stroke, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

780 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with advanced left ventricular heart failure, a condition where the heart struggles to pump blood effectively. The study compares the new BrioVAD System (a heart pump device) with the existing HeartMate 3 device to determine if it performs as well or better. Suitable candidates experience difficulty breathing during mild activities due to heart failure and have not found relief with other treatments. Participants must have a specific heart function level and be approved for a device to assist their heart in pumping. As an unphased trial, this study offers a unique opportunity to contribute to pioneering research that could enhance future heart failure treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the BrioVAD System is safe for treating advanced, refractory, left ventricular heart failure?

Research has shown that the BrioVAD System is being tested to determine if it is as safe and effective as the HeartMate 3, a device already approved for treating left ventricular heart failure. The BrioVAD System remains under study and has not yet received FDA approval. While it appears promising, complete safety information is not yet available.

Since the trial is not in its early stages, the BrioVAD has already met some basic safety standards in earlier studies. However, ongoing testing means that all possible side effects or risks are not fully known. Prospective participants should consult their doctor to understand the potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The BrioVAD System is unique because it offers a new approach to supporting heart function in patients with left ventricular heart failure. Unlike current ventricular assist devices, which are often bulky and require invasive surgery, the BrioVAD System is designed to be more compact and less invasive, potentially making it easier for patients to tolerate and recover from the procedure. Researchers are excited about this treatment because it promises to improve patient outcomes with fewer complications and a more straightforward implantation process compared to existing devices like the HeartMate 3.

What evidence suggests that the BrioVAD System is effective for advanced heart failure?

This trial tests the BrioVAD System to determine if it performs as well as the HeartMate 3 in treating advanced heart failure. Participants will receive either the BrioVAD System or the HeartMate 3. The trial aims to demonstrate that the BrioVAD System is equally effective in helping patients survive until a heart transplant, recover heart function, or maintain a good quality of life for at least six months. Although long-term data is not yet available, the FDA has approved trials based on promising early results. The system is designed to enhance the heart's ability to pump blood, potentially offering a new option for those with severe heart failure. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Inclusion 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.

I have given my consent to participate.

I am using birth control and my pregnancy test was negative.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the BrioVAD System or HeartMate 3 for the treatment of advanced, refractory left ventricular heart failure

6 months

Regular follow-up visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment, including survival to transplant, recovery, or LVAD support

24 months

Periodic follow-up visits

Long-term monitoring

Evaluation of long-term safety and effectiveness using INTERMACS adverse event terms and definitions

24 months

What Are the Treatments Tested in This Trial?

Interventions

• BrioVAD System

How Is the Trial Designed?

Group I: BrioVAD System Experimental Treatment 1 Intervention

BrioVAD® Left Ventricular Assist System (BrioVAD® System) by BrioHealth Solutions, Inc.

Group II: HeartMate 3 Active Control 1 Intervention

HeartMate 3 System by Abbott

Who Is Running the Clinical Trial?

BrioHealth Solutions, Inc.

Lead Sponsor

Trials

1

Recruited

780+

Citations

1. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/multicenter-trial-launched-to-evaluate-new-lvad-option-for-advanced-heart-failure

Trial Evaluates New LVAD Option for Advanced HF The primary endpoint is a composite of survival to transplantation, cardiac recovery, or six months (24 months in the study's long-term phase) ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1053249825018236

Design and rationale for the clinical investigation of a novel ... INNOVATE is designed to evaluate safety and efficacy of the BrioVAD by demonstrating non-inferiority to the HeartMate 3 (HM3; Abbott Labs, Chicago, IL).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06310031

NCT06310031 | Investigation of the BrioVAD System for ... 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 ...

4. jhltonline.org jhltonline.org/article/S1053-2498(25)01823-6/abstract

Design and rationale for the clinical investigation of a novel ... INNOVATE is designed to evaluate safety and efficacy of the BrioVAD by demonstrating non-inferiority to the HeartMate 3 (HM3; Abbott Labs, Chicago, IL).

5. journal.hsforum.com journal.hsforum.com/index.php/HSF/article/download/8367/9299/77815

An Overview of the Current Ventricular Support Devices ... Due to these promising results, the device gained FDA ap- proval for a clinical trial in the United States in 2024. The. INNOVATE trial aims to ...

6. briohealthsolutions.com briohealthsolutions.com/briovad/

BrioVAD - BrioHealth Solutions CAUTION: The BrioVAD® System is an investigative device and is not approved by the U.S. Food and Drug Administration for commercial use.