Laplace Interventional has announced that the US Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for TRIUMPH, the pivotal trial of its transcatheter tricuspid valve replacement (TTVR) system.
TRIUMPH is a prospective, multicentre 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 enrolment of approximately 400 patients at up to 75 sites, randomised 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 (TEER).
Laplace has announced the appointment of three global principal investigators for the TRIUMPH trial: Charanjit Rihal (Mayo Clinic, Rochester, USA), Kashish Goel (Vanderbilt University Medical Center, Nashville, USA) and Brandon Jones (Providence St Vincent Medical Center, Portland, USA). The three clinical institutions were the top three enrollers in the Laplace US early feasibility study (EFS).
“The Laplace safety and efficacy data in the EFS so far is very impressive. This potentially provides new options for patients with advanced TR due to its unique design,” said Rihal. “We are looking forward to testing it further in TRIUMPH which will contribute important clinical data on TTVR.”
“The FDA approval of the pivotal trial builds on the excellent clinical outcomes observed in the Laplace EFS study,” said Goel. “We are excited to participate in the trial as Laplace solves a significant unmet need for TR patients.”
“It’s a huge honour to partner with Drs Rihal, Goel, and the Laplace team in leading the TRIUMPH trial,” said Jones. “Our patients are desperate for the next generation of transcatheter tricuspid valve therapies, and based on our early feasibility experience, we have great optimism that this unique system can treat a wider variety of anatomies and improve on the safety profile of the limited, currently available, commercial technologies.”
“FDA IDE approval of TRIUMPH marks a significant milestone for Laplace and for the advancement of transcatheter therapy in tricuspid valve disease,” said Ramji Iyer, founder and CEO of Laplace Interventional. “We appreciate the collaboration of the investigators and study teams involved in this program and look forward to the clinical insights that will emerge from the study.”
