Minneapolis Heart Institute Foundation® (MHIF) enrolled the first patient in the TRIVITA US pivotal study evaluating the TriNova™ transcatheter tricuspid valve replacement (TTVR) (from Minnesota‑based VDyne Inc.). This is an important milestone in efforts to advance treatment options for patients living with severe tricuspid regurgitation (TR), which involves a leaky tricuspid heart valve. The first patient in TRIVITA was enrolled by Konstantinos Voudris, MD, PhD, MHIF Researcher and Director of the Center for Valve and Structural Heart Disease at Allina Health Minneapolis Heart Institute. The procedure was performed by Dr. Konstantinos Voudris, Dr Vinayak Bapat, Dr Nadira Hamid, Dr Mario Goessl and Marcus Burns.
"The start of the US pivotal study represents an important step forward in developing improved treatment options for patients with tricuspid regurgitation,” said Nadira Hamid, MD, Director of Interventional Echocardiography at Allina Health Minneapolis Heart Institute, Scientific Director of the Echocardiography Core Laboratory at MHIF and Global Co‑Principal Investigator for the TRIVITA pivotal study. “The data from early feasibility studies and the ongoing VISTA trials have been very encouraging and have provided promising preliminary safety and performance data of TriNova. I am looking forward to this next phase of the TriNova clinical program as we build enrollment momentum in the TRIVITA pivotal trial.”
TRIVITA is a global, multicenter pivotal study designed to evaluate the safety and effectiveness of the TriNova TTVR system in patients with severe TR who are suitable for valve replacement. The trial will enroll patients at up to 70 sites across the United States and Europe and will compare TriNova head‑to‑head with the commercially available TTVR system. MHIF is the first enrolling site in Minnesota.
Tricuspid regurgitation is a common and often under‑recognized valve disease in which the tricuspid valve does not close properly, allowing blood to leak backward in the heart. For many patients, open‑heart surgery is high‑risk or not an option, making less invasive catheter‑based therapies an important area of ongoing research. Through participation in the TRIVITA pivotal study and other VDyne clinical programs, MHIF is helping to generate the evidence needed to establish safe, effective transcatheter treatment options for patients with advanced TR.
Read the VDyne news release to learn more about the TriNova system and the TRIVITA pivotal trial.
