The INNOVATE Trial

The INNOVATE Trial for the BrioVAD® System

A clinical study evaluating a new left ventricular assist device for advanced heart failure

The INNOVATE Trial

The INNOVATE Trial with the BrioVAD® System

A clinical study evaluating a new left ventricular assist device for advanced heart failure

LVAD THERAPY

In the later stages of heart failure, when the heart muscle can no longer pump to meet the demands of the body, the use of mechanical circulatory support devices may be needed. Called LVADs (left ventricular assist devices), these devices help the heart effectively pump blood throughout your body and enable you to participate in daily activities.

THE BRIOVAD SYSTEM

The BrioVAD System is a new LVAD that uses advanced technology designed to reduce complications from treating advanced heart failure. The smaller pump fits small patients, and its wearable components are lightweight and have few connections. More than 300 patients outside the U.S. have received the BrioVAD pump.*

THE INNOVATE TRIAL

The INNOVATE Trial is evaluating the BrioVAD System at leading medical centers across the U.S. The trial will look at how safe and effective the BrioVAD System is and assess complications and quality of life – or how you feel with the LVAD. The trial will also see if patients living with the BrioVAD System spend less time in the hospital.

HEAR FROM A HEART FAILURE CARDIOLOGIST ABOUT ADVANCED HEART FAILURE, LVADS AND THE INNOVATE TRIAL

FREQUENTLY ASKED QUESTIONS

Your heart failure care team will determine if you are eligible to be part of the INNOVATE Trial. They will perform a series of tests and evaluations to decide.

You will be evaluated based on the following criteria. You may be eligible for the INNOVATE Trial if you:

  • Are 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.
  • Have a left ventricular ejection fraction (LVEF) ≤25% or LVEF <30% on inotropes or temporary 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

For a full list of inclusion/exclusion criteria, please contact an INNOVATE Trial site near you.

To determine if there is a site near you, please search on the map below.

The BrioVAD System is an investigational LVAD designed to reduce complications from treating advanced heart failure. The BrioVAD System is different from other LVAD technology in many ways:

  • The pump uses advanced technology designed to minimize blood damage and potentially reduce blood clots
  • The smaller pump fits patients better
  • The controller and battery are lighter and designed with fewer connections

The driveline that connects the pump to the controller is flexible and smaller for better patient comfort and to potentially reduce infection where it exits the body

More than 300 patients outside the U.S. have received the BrioVAD pump.*

The INNOVATE Trial is a randomized study, which means participants will be assigned treatment via a random selection process, and it is not possible to request one LVAD over the other. Participants have a 2-in-3 chance of receiving the new BrioVAD System.

Participating in a clinical study such as the INNOVATE Trial offers you access to LVAD treatment and scheduled check-ups as part of the trial plan. This may result in more detailed evaluation of you and your advanced heart failure care.

In addition, development of new treatments depends on patient participation in clinical trials. The knowledge gained from the INNOVATE Trial will be used to help patients now and in the future, in your community and across the country.

You will be evaluated at regular times: one, three, six, 12, 18 and 24 months after you receive your LVAD. At these check-ups, you will be asked to complete questionnaires, forms, lab testing, echocardiograms and physical examinations.

The same check-ups are required regardless of which LVAD you receive.

No, however, participants may receive compensation for travel costs related to study check-ups that are not part of routine LVAD care.

INNOVATE TRIAL LOCATIONS

The INNOVATE Trial is currently available at these leading medical centers, and additional sites will be added soon. If you have advanced heart failure and would like more information about the INNOVATE Trial, please contact an INNOVATE Trial site near you.

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Description

ADDITIONAL LVAD RESOURCES

ADDITIONAL

LVAD RESOURCES

LVAD Overview
Colorado Program for Patient-Centered Decisions – LVADs

LVAD Decision Making Guide
The Left Ventricular Assist Device Decision Aid Project

Information About Participating in Clinical Trials
National Institute on Aging

INNOVATE Trial Information
ClinicalTrials.gov

*The BrioVAD Pump is the same as the pump used in the CH-VAD System outside the United States