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.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with advanced heart failure
- Are in need of a left ventricular assist device
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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
- 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
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
Investigation of a Novel, magNetically levitated VAD for the treatment of refractOry left Ventricular heArT failurE (INNOVATE Trial)
Principal Investigator
Jeffrey
Keenan
Protocol Number
PRO00116116
NCT ID
NCT06310031
Enrollment Status
Pending Open to Enrollment