JenaValve revealed that patient enrollment began in its ARTIST study, a randomized controlled trial (RCT) evaluating its Trilogy transcatheter heart valve (THV) system compared to surgical aortic valve replacement (SAVR) in patients with aortic regurgitation (AR).

The ARTIST trial aims to offer evidence to treat moderate-to-severe and severe AR in patients that aren’t at high-risk for SAVR. According to the company, it’s the first randomized study comparing SAVR to transcatheter aortic valve replacement (TAVR) in AR patients.

The company believes the study will continue to elevate the Trilogy system’s versatility, following outcomes achieved in AR patients that are at high surgical risk.

The Trilogy THV system received CE mark approval in 2021, providing European physicians with the first TAVR device with true dual-disease treatment capabilities. In the U.S., Trilogy is limited to investigational use only.

“ARTIST is a landmark study designed to answer a critical question of how to best treat patients with severe AR,” said Dr. Torsten Vahl, principal investigator of the ARTIST trial and interventional cardiologist at Columbia University Irving Medical Center. “Building on ALIGN-AR, which established TAVR as a solution for high-risk AR patients, ARTIST has the potential to expand TAVR to a broader population of severe AR patients. It is also the first prospective head-to-head evaluation of TAVR versus surgery ever conducted in this patient population. The results will provide critical data to guide future treatment decisions in the structural heart community.”

“The launch and enrollment of ARTIST marks a defining moment for both JenaValve and the structural heart field,” added John Kilcoyne, CEO of JenaValve. “ARTIST reflects our commitment to generating the highest level of clinical evidence as we work to bring a less invasive solution to a larger group of patients suffering from this challenging disease.”