Open for Enrollment Soon
This study will open for enrollment soon. Please contact the study team for more information and check back frequently.
INNOVATE Trial (Heart Failure) - Clinical Trial
Email for Information
rachael.abuin@duke.edu
What is the Purpose of this Study?
We are doing this study to find out if an experimental medical device called the BrioVAD Left Ventricular Assist System (BrioVAD System) is a safe and effective option for people who have advanced heart failure.
What is the Condition Being Studied?
Heart Failure
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with advanced heart failure
- Are in need of a left ventricular assist device
For more information about this study, contact the study team at rachael.abuin@duke.edu.
Age Group
Adults
What is Involved?
If you choose to join this study, you will get a random assignment to either:
- Get the BrioVAD System (investigational study device) implanted; OR
- Get the HeartMate 3 LVAS (FDA approved control device) implanted
At other visits during the study, you will:
- Have blood tests, echocardiograms, chest x-rays, and CT scans
- Complete neurological and functional assessments
- Complete quality of life surveys
- Stay in touch with the study team for up to 2 years after your procedure
Study Details
Full Title
Investigation of a Novel, magNetically levitated VAD for the treatment of refractOry left Ventricular heArT failurE (INNOVATE Trial)
Principal Investigator
Thoracic Surgeon
Protocol Number
IRB:
PRO00116116
NCT:
NCT06310031
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon
More Information
Email rachael.abuin@duke.edu