JenaValve’s ARTIST RCT of Trilogy System in AR Begins Enrollment

July 17, 2025—JenaValve Technology, Inc. recently announced commencement of patient enrollment in both the transcatheter aortic valve replacement (TAVR) arm and the surgical aortic valve replacement (SAVR) arm of the ARTIST randomized controlled trial.

According to the company, ARTIST is evaluating the safety and effectiveness of TAVR with the company’s Trilogy transcatheter heart valve (THV) system compared to SAVR in patients with aortic regurgitation (AR). The trial is designed to provide evidence for the treatment of moderate-to-severe and severe AR in patients that are not at high risk for SAVR.

JenaValve advised that the Trilogy THV system received CE Mark approval in Europe. In the United States, the device is limited to investigational use only.

The company noted that the first patient in the trial was treated by Raj Makkar, MD, at Cedars-Sinai Medical Center in Los Angeles, California.

“It’s incredibly rewarding to have enrolled and treated the first randomized patient in the ARTIST trial,” commented Dr. Makkar in the company’s press release. “In a single day, we performed multiple Trilogy cases, including as mentioned our first ARTIST case as well as implanting Trilogy in a patient with left ventricular assist device (LVAD)-related AR disease who was enrolled into the JENA-VAD Registry.

Dr. Makkar continued, “These experiences highlight just how much demand exists for less invasive solutions in this complex and undertreated population; it’s a glimpse into how the Trilogy valve could reshape care for patients with AR.”

The principal investigator of the ARTIST trial is Torsten Vahl, MD, interventional cardiologist at Columbia University Irving Medical Center in New York, New York.

“ARTIST is a landmark study designed to answer a critical question of how to best treat patients with severe AR,” stated Dr. Vahl in JenaValve’s press release. “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.”