Laplace Interventional has announced that the first three patients have been enrolled and treated in the randomised cohort of the TRIUMPH pivotal trial.
These patients were treated at Ballad Health (Kingsport, USA) and Oklahoma Heart Institute (Tulsa, USA) by structural heart teams headed by Gaurav Rana and Kamran Muhammad, respectively.
Laplace Interventional is developing a prosthetic valve to treat tricuspid regurgitation (TR) that is delivered through a minimally invasive procedure, either through a vein in neck or groin.
TRIUMPH is a prospective, multicentre pivotal investigational device exemption (IDE) study where patients are randomised 2:1 against commercial transcatheter tricuspid valve replacement (TTVR).
TRIUMPH pivotal trial is headed by three global principal investigators: Charanjit Rihal (Mayo Clinic, Rochester, USA), Kashish Goel (Vanderbilt University Medical Center, Nashville, USA), and Brandon Jones (St Vincent Medical Center, Portland USA).
“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, founder and CEO of Laplace Interventional. “Treating these first set of patients is of great significance to the company and sets the early clinical momentum required for the pivotal trial.”
