A breakthrough study found that the TriClip™ transcatheter edge-to-edge repair (TEER) system was safe for patients with severe tricuspid regurgitation, reduced the severity of tricuspid regurgitation, and was associated with an improvement in quality of life.
The TRILUMINATE™ Pivotal study is the world's first randomized clinical trial to evaluate transcatheter tricuspid valve repair in patients with severe tricuspid regurgitation versus medical therapy. David H. Adams, MD, the Marie-Josée and Henry R. Kravis Professor and System Chair of Cardiovascular Surgery at Icahn Mount Sinai, and Cardiac Surgeon-in-Chief of the Mount Sinai Health System, is the national co-principal investigator along with Paul Sorajja, MD, Roger L. and Lynn C. Headrick Family Chair for the Minneapolis Heart Institute Foundation.
The trial evaluates the superiority of TriClip compared to medical therapy in treating patients with severe, symptomatic tricuspid regurgitation (TR) who are at intermediate or greater risk for open-heart surgery. It met its composite primary endpoint demonstrating superiority of the TriClip system compared to the control group (win ratio 1.48; 95% confidence interval, 1.06 to 2.13; p=0.02), primarily driven by improvement in quality of life. Mortality or tricuspid valve surgery and heart failure hospitalizations did not appear different between the groups at one year.
Data for the first-of-its-kind minimally invasive device designed specifically for tricuspid heart valve repair were presented at the American College of Cardiology's 72nd Annual Scientific Session Together With World Congress of Cardiology (ACC.23/WCC) held in New Orleans March 4-6. These data were simultaneously published in the New England Journal of Medicine, with Dr. Adams as the senior author.