INNOVATE Trial (Heart Failure)

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
For more information about this study, contact the study team at rachael.abuin@duke.edu.

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
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

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
ClinicalTrials.gov