TRIUMPH is a prospective, multicenter pivotal study designed to assess the safety and effectiveness of Laplace TTVR system in patients with severe tricuspid regurgitation (TR). The trial has a target enrollment of approximately 400 patients at up to 75 sites, randomized 2:1 against commercial TTVR. In addition, up to 150 patients will be enrolled in a single arm registry who are ineligible for commercial TTVR and suboptimal for transcatheter edge-to-edge repair.

Laplace is also pleased to announce the appointment of three global principal investigators for the TRIUMPH trial: Dr. Charanjit Rihal, MD, Interventional Cardiologist at Mayo Clinic, Rochester; Dr. Kashish Goel, MD, Director of Transcatheter Valve Interventions at Vanderbilt University Medical Center, Nashville; and Dr. Brandon Jones, MD, Medical Director of Structural Heart Program at Providence St. Vincent Medical Center, Portland. The three clinical institutions were the top three enrollers in the Laplace US Early Feasibility Study (EFS).