JenaValve has announced that patient enrolment has begun in the ARTIST study, a randomised controlled trial evaluating the safety and effectiveness of the Trilogy transcatheter heart valve system compared to surgical aortic valve replacement (SAVR) in patients with aortic regurgitation (AR).
The study is now enrolling patients in both transcatheter and surgical arms with the first case being performed in Los Angeles, USA, at Cedars-Sinai Medical Center.
ARTIST is designed to provide evidence for the treatment of moderate-to-severe and severe AR in patients that are not at high-risk for surgical aortic valve replacement and is the first ever randomised study comparing SAVR versus transcatheter aortic valve implantation (TAVI) in AR patients.
“It’s incredibly rewarding to have enrolled and treated the first randomised patient in the ARTIST trial,” said Raj Makkar (Cedars-Sinai Medical Center, Los Angeles, USA). “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 JENAVAD Registry. 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.”
“ARTIST is a landmark study designed to answer a critical question of how to best treat patients with severe AR,” said Torsten Vahl, principal investigator of the ARTIST trial and interventional cardiologist at Columbia University Irving Medical Center (New York, USA). “Building on ALIGN-AR, which established TAVI as a solution for high-risk AR patients, ARTIST has the potential to expand TAVI to a broader population of severe AR patients. It is also the first prospective head-to-head evaluation of TAVI 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 enrolment of ARTIST marks a defining moment for both JenaValve and the structural heart field,” said John Kilcoyne, chief executive officer 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.”
