IDE for TRIUMPH Pivotal Trial of Laplace’s TTVR System

July 2, 2026—Laplace Interventional, Inc. announced that the FDA has approved an investigational device exemption (IDE) for the TRIUMPH pivotal trial evaluating the company’s transcatheter tricuspid valve replacement (TTVR) system.

According to the company, TRIUMPH is a prospective, multicenter study designed to assess the safety and effectiveness of the 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.

The company stated that patients in the study will be randomized 2:1 with the Laplace TTVR and a commercial TTVR device. In addition, a single-arm registry will enroll up to 150 patients who are ineligible for commercial TTVR and suboptimal for transcatheter edge-to-edge repair.

Laplace advised that the three global principal investigators of the TRIUMPH trial are Charanjit Rihal, MD; Kashish Goel, MD; and Brandon Jones, MD.

Dr. Rihal is an interventional cardiologist at the Mayo Clinic in Rochester, Minnesota. Dr. Goel is Director of Transcatheter Valve Interventions at Vanderbilt University Medical Center in Nashville, Tennessee. Dr. Jones is Medical Director of Structural Heart Program at Providence St. Vincent Medical Center in Portland, Oregon.

Their institutions were the top three enrollers in the Laplace United States Early Feasibility Study (EFS), noted Laplace Interventional.

“The Laplace safety and efficacy data in the EFS so far is very impressive,” commented Dr. Rihal in the company’s press release. “This potentially provides new options for patients with advanced TR due to its unique design. We are looking forward to testing it further in TRIUMPH which will contribute important clinical data on TTVR.”