The Duke Department of Surgery has successfully completed its first implantation of the BrioVAD™ Left Ventricular Assist System, marking a major milestone in the national INNOVATE Trial. The procedure aims to evaluate the safety and effectiveness of this advanced device in patients with advanced heart failure.
BrioVAD is a magnetically levitated left ventricular assist device (LVAD) designed to support patients whose hearts can no longer pump enough blood on their own. The trial compares the BrioVAD to the HeartMate 3, the only FDA-approved LVAD on the market.
“While the HeartMate 3 is an excellent device, there continue to be challenges in the long-term management of LVAD patients related to infections of the device power cord, thrombosis and bleeding, and right heart failure,” said thoracic surgeon Jeffrey E. Keenan, MD, the study’s principal investigator.
The BrioVAD system offers several potential advantages over the HeartMate 3, including a more efficient blood path that may enhance biocompatibility; a smaller pump housing for less anatomical disruption; a thinner, more flexible power cord to reduce infection risk; and a lighter external controller that could improve patients’ mobility and overall experience.
The study requires close collaboration across surgical, cardiac, and research teams, Dr. Keenan said. This includes seamless coordination from patient evaluation through surgery, ICU care, and long-term outpatient follow-up.
“I always say that taking care of the advanced heart failure patient is truly a team sport,” he said.
The trial is expected to run for five years and aims to enroll more than 700 patients. Duke is one of only eight centers participating in the initial safety phase, which will conclude after 30 patients are enrolled and evaluated to confirm the device’s safety and efficacy. Participants undergo regular follow-up, including imaging, functional assessments, and quality-of-life surveys.
The patient who received the BrioVAD implant is recovering well and approaching discharge from the ICU.
“We are grateful our first implant has gone well, and our early experience with the pump is encouraging,” Dr. Keenan said. “It is exciting to be a part of this trial, and we look forward to continuing to learn more about this device as we gain experience, with the ultimate goal of saving lives and helping patients live high-quality, independent lives.”
For more information or to inquire about eligibility, contact the study team at rachael.abuin@duke.edu.