First patients treated for TRIUMPH trial focused on new TTVR tech
The first three patients have been enrolled and treated in the TRIUMPH pivotal trial evaluating the safety and efficacy of Laplace Interventional's investigational transcatheter tricuspid valve replacement (TTVR) device. It can be placed using transjugular or transfemoral access.
The patients were treated at Ballad Health in Kingsport, Tennessee, and the Oklahoma Heart Institute in Tulsa by structural heart teams headed by Gaurav Rana, MD, and Kamran Muhammad, MD, respectively.
The Laplace valve is designed to treat tricuspid regurgitation (TR). TRIUMPH is a prospective, multicenter pivotal investigation device exemption (IDE) study where patients are randomized 2:1 against a commercially available TTVR device. The pivotal trial is headed by three global co-principal investigators: Charanjit Rihal, MD, an interventional cardiologist at Mayo Clinic, Rochester; Kashish Goel, MD, director of transcatheter valve interventions at Vanderbilt University Medical Center; and Brandon Jones, MD, medical director of structural heart at Providence St. Vincent Medical Center in Portland, Oregon.
The valve can treat varying anatomies and is able to compensate for native leaflet abnormalities such as tethered leaflets, flail leaflets, leaflet paucity and carcinoid heart disease. It was also designed to be gentle on a patient's anatomy.
"On behalf of the Laplace team, I would like to congratulate Dr. Rana and his team at Ballad Health, as well as Dr. Muhammad and his team at Oklahoma Heart Institute, on treating the first patients in the TRIUMPH pivotal study," said Ramji Iyer, PhD, founder and CEO of Laplace Interventional, in a statement. "Treating these first set of patients is of great significance to the company and sets the early clinical momentum required for the pivotal trial."
One-year data from Laplace's Transjugular Early Feasibility Study will be presented by Goel at 2:15 p.m. on Nov. 2 at TCT 2026 in San Diego.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]