AdventHealth Participating in INNOVATE Clinical Trial to Evaluate BrioVAD System for Heart Failure

Under the leadership of principal investigator Andrija Vidic, DO, the AdventHealth Transplant Institute is participating in the Investigation of a Novel, magNetically Levitated VAD for the Treatment of refractOry Left Ventricular heArT failure (INNOVATE) clinical trial to evaluate the safety and efficacy of the BrioVAD System, a new left ventricular assist device (LVAD) for the treatment of advanced, refractory, left ventricular heart failure. This Phase 3, multi-center, randomized study is comparing BrioVAD to the HeartMate 3 LVAD and is the first clinical study to compare two LVADs that belong to the same category of fully magnetically levitated LVAD. AdventHealth cardiothoracic surgeons Ahmad Zeeshan, MD; Michael A. Bishop, DO; Linda Bogar, MD; and Daniel Rinewalt, MD, are assisting with the trial and to date, AdventHealth has enrolled seven patients in the trial and implanted three with the new BrioVAD device.

Addressing LVAD Challenges and Complications

An LVAD is a surgically implanted mechanical pump that helps a failing heart's left ventricle pump oxygen-rich blood to the body. It consists of an internal pump, a driveline through the skin, and an external controller and battery pack. The earliest LVAD pumps were large and resulted in a high incidence of pump thrombosis and complications, including stroke. The HeartMate 3, approved by the FDA in 2017 as a bridge to transplant and in 2018 as a destination therapy, is currently the only LVAD on the market.

“There are great things about HeartMate 3, but challenges remain,” shares Dr. Vidic. “In particular, patients who are small struggle with it. The pump can rub up against the chest cavity and cause pain. If a patient’s body surface area is below 1.5 square meters, surgeons are hesitant to even implant it, limiting treatment options.”

An investigational LVAD designed to reduce complications from treating advanced heart failure, the BrioVAD System is different in several ways:

• The pump uses advanced technology designed to minimize blood damage and potentially reduce blood clots.
• The pump is smaller to enhance patient comfort and to fit patients with smaller body surface area (BSA).
• The controller and battery are lighter and designed with fewer connections.
• The driveline that connects the pump to the controller is flexible and smaller to potentially reduce infection where it exits the body.

“BrioVAD was designed to be a much smaller pump with the ability to generate the same amount of flow,” explains Dr. Vidic. “Additionally, the pump is more pulsatile to hopefully enhance passive flow in the native heart and reduce complications.”

The BrioVAD system evolved from the CH-VAD system that was studied and approved for marketing in China in 2021.

Study Design and Inclusion Criteria

INNOVATE is a multi-center, prospective, non-blinded, randomized (2 BrioVAD: 1 HeartMate 3), controlled, non-inferiority study designed as a staged pivotal study with a pre-defined safety phase. Primary endpoints include a composite of survival to transplant, cardiac recovery, or 6 months (short-term) or 24 months (long-term) of LVAD support free from debilitating stroke (modified Rankin Scale > 3), or reoperation to replace the pump. The study will also evaluate days spent in a hospital, skilled nursing facility, or inpatient rehabilitation.

To be considered for the INNOVATE trial, patients must meet the following inclusion criteria:

• Classified as New York Heart Association (NYHA) Class IV with advanced heart failure refractory to advanced heart failure management or NYHA Class III with dyspnea upon mild physical activity.
• Have a left ventricular ejection fraction (LVEF) ≤25% or LVEF <30% on inotropes or temporary mechanical circulatory support (MCS).
• Are inotrope dependent or have a cardiac index (CI) ≤ 2.2 liters/min/m2, while not on inotropes, and meet one of the following criteria:
  • Are on optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond or are not able to tolerate OMM; or
  • Have advanced heart failure for at least 14 days and are dependent on an intra-aortic balloon pump (IABP) or temporary mechanical circulatory support device (MCSD) for at least seven days.
• Are at least 18 years old.

Study participants will be evaluated at one, three, six, 12, 18 and 24 months after receiving their LVAD. At these check-ups, they will be asked to complete questionnaires, forms, lab testing, echocardiograms and physical examinations.

“Our study team meets every week to evaluate patients who have been referred for advanced heart failure therapies, including LVAD or transplant,” says Dr. Vidic. “If a patient is approved for LVAD therapy, we screen them for the INNOVATE trial based on the eligibility criteria. Then, our financial coordinators will reach out to their insurance to see if they have trial coverage. If they do, we'll talk to the patient to see if they're interested in participating in a clinical trial. Most of the patients who have been approached about the study have been excited to participate.”

Advancing Heart Failure Care

By participating in this pivotal trial, AdventHealth hopes to strengthen its role as a leader in cardiac innovation.

“We are one of the largest LVAD programs in the country and were selected to participate in the INNOVATE trial because of our volume and outcomes,” share Dr. Vidic. “In the past, we’ve had to turn down patients for being too small and unable to tolerate HeartMate 3. We believe it is important to be engaged in research and new technologies that will push the field forward, improve outcomes and make new treatment options available to patients suffering from some of the most complex heart conditions.”

Learn more about the INNOVATE trial.